Regulatory

Senior Manager, Regional Regulatory Lead - US (Hematology)

**Senior Manager, Regional Regulatory Lead – US Hematology**

**CSL Research & Development**

**Location:**  King of Prussia, PA or Waltham, MA

**Work Arrangement:**  Hybrid – three days onsite per week

**Reports To:**  Executive Director, Head of Regulatory

CSL’s Research & Development organization is accelerating innovation to deliver greater impact for patients. Through a project-led structure and a focus on collaboration, we are building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL means becoming part of an agile organization committed to developing innovative therapies that make a meaningful difference for patients worldwide.

**Position Overview**

CSL is seeking a Senior Manager, Regional Regulatory Lead – US Hematology to join Global Regulatory Strategy (GRS) within Global Regulatory Affairs (GRA). This individual will contribute regional regulatory expertise to the development and execution of integrated global regulatory strategies for assigned products, with a focus on the US market and FDA requirements.

The Regional Regulatory Lead (RRL) partners closely with Global Regulatory Leads (GRLs), cross-functional regulatory teams, Regulatory CMC, and commercial stakeholders to support regulatory strategy, product development, submissions, and health authority interactions. This role requires strong regulatory knowledge, sound judgment, effective cross-functional collaboration, and the ability to navigate a complex, matrixed organization to achieve timely and successful regulatory outcomes.

The successful candidate will serve as a regional regulatory expert, provide guidance on US regulatory requirements and pathways, and help identify opportunities and mitigate risks across developmental, new, and marketed products.

**Key Responsibilities**

- **Regional Regulatory Strategy:**  Contribute US regulatory expertise to the development and execution of integrated global regulatory strategies for assigned products, ensuring alignment with global objectives, regional requirements, commercial insights, and patient needs.
- **Health Authority Engagement:**  Develop and maintain productive relationships with the FDA and support or lead assigned health authority interactions and negotiations in partnership with the Global Regulatory Lead and Regulatory Therapeutic Area leadership.
- **Regulatory Submissions:**  Lead or contribute to regional regulatory activities for investigational, new, and marketed products, including submission preparation, core document development, briefing books, pediatric plans, and other regulatory deliverables.
- **US Submission Documentation:**  Oversee the preparation and coordination of required Module 1 documentation for US regulatory submissions and support responses to health authority questions and comments.
- **Cross-Functional Collaboration:**  Partner with Global Regulatory Leads, Global Regulatory Affairs Strategy Team (GRAST) members, Regulatory CMC, regional commercial operations, and other stakeholders to ensure consistent regulatory positions, informed decision-making, and effective execution of regulatory plans.
- **Regulatory Guidance and Risk Assessment:**  Provide regional expertise on FDA requirements, regulatory pathways, filing categories, processes, and ways of working. Assess regulatory risks, identify opportunities, and advise internal stakeholders on approaches to address development and approval challenges.
- **Regulatory Strategy and Intelligence:**  Contribute to regulatory strategy development, cross-functional document reviews, and competitive regulatory intelligence to inform product decisions and support successful regulatory outcomes.
- **Execution and Communication:**  Drive timely completion of regional regulatory deliverables, promote accountability across project teams, and communicate global regulatory strategies and decisions to relevant regional commercial stakeholders.
- **Stakeholder Relationships:**  Build strong working relationships across global and regional regulatory teams, ensuring effective communication, alignment, and collaboration throughout the product lifecycle.

**Qualifications**

- Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, clinical medicine, or a related life science field required.
- Advanced degree in a related discipline, such as an MS, PhD, MD, DVM, or MBA, preferred.
- Minimum of seven years of experience in the biotechnology or pharmaceutical industry, including at least five years of regulatory affairs experience.
- At least three years of experience supporting regulatory activities for developmental products.
- Experience working in Regulatory Affairs with responsibility for interaction with at least one health authority.
- Developing knowledge of pharmaceutical or biological product development and regulatory requirements for development and approval in a major region, such as the US, EU, or Japan.
- Experience working within cross-functional teams and matrixed reporting structures.
- Ability to evaluate options, exercise sound judgment, and make informed decisions in complex situations.

The expected base salary range for this position at hiring is $150,000 - $180,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the time of this posting in MA. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.

\#LI-HYBRID

**About CSL Behring**

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit [https://www.csl.com/](<https://www.csl.com/>) and CSL Plasma at [https://www.cslplasma.com/](<https://www.cslplasma.com/>).

**Our Benefits**

For more information on CSL benefits visit [How CSL Supports Your Well-being | CSL](<https://www.cslbenefits.com/csl/candidates>).

**You Belong at CSL**

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

**Equal Opportunity Employer**

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit [https://www.csl.com/accessibility-statement](<https://www.csl.com/accessibility-statement>).

Pennsylvania

Daiichi Sankyo

Research Pharmacist

Job Description

Job Title: Research Pharmacist

Job Requisition ID: 2315

Posting Start Date: 10/8/26

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

**Job Summary**

The Research Pharmacist will be responsible for providing input in the development, management and training of investigational products at a program and protocol level (i.e. Investigational Product (IP) manuals/pharmacy manuals/Dose Preparation Instructions (DPI) for utilization by clinical sites). The Research Pharmacist will also contribute to the review and approval of template documents for protocols, pharmacy manuals, and DPI. The Research Pharmacist provides expertise on clinical site/pharmacy operations and best practices as well as aseptic preparation guidelines for injectables.

**Job Description**

**Responsibilities**

- Support and management of clinical studies for all sponsored trials, as well as Externally Sponsored Research (ESR) customers. Serve as the Subject Matter Expert (SME) for R&D for all questions related to clinical pharmacy practice at sites and IMP or comparator related questions.
- Provide strategic leadership of oversight of all clinical site and patient focused training materials. Collaborate with other functional areas as necessary (eg, Clinical Supply Planning and Operations (CSP&O), Chemistry Manufacturing & Controls (CMC), Clinical Operations, etc.).
- Has a focus on strategic and operational excellence; Provide input in Patient Focused Initiatives. Ensure a site-friendly and patient-friendly focus for all site/patient facing materials. Provide input on the design of Pharmacy Manuals, Patient Wallet cards, Patient ILD Educational information and other relevant patient or site-facing materials
- Deliver excellence in clinical trials through the use of harmonized tools, processes and systems, to deliver cost-effective, high-quality IP Handling information and training according to agreed timelines
- Proactively ensure quality and compliance through risk identification and mitigation plans, strategic planning and execution, and overall design input.
- Serve as regular reviewer on the Protocol Review Group (PRG).
- Responsible for reviewing all protocol profiles, v1 protocols, and protocol amendments with the perspective of a clinical pharmacist, considering both clinical and logistical concerns at the site level. Work with study teams to resolve feasibility concerns. Ensure consistent guidance is provided to sites between protocol and other related documents (eg, pharmacy manual, DPI). Provide feedback to ensure protocols are written in a site-friendly manner to avoid any feasibility concerns.
- Serve as a regular review for Externally Sponsored Research (ESR) concepts and high-risk protocols.

**Qualifications**

**Education Qualifications**

- PharmD, or equivalent, required

**Experience Qualifications**

- 7 years of Clinical Pharmacy or equivalent pharmaceutical/biotech industry experience. preferred
- Hospital pharmacy experience required.
- Completion of a post-PharmD Industry Fellowship or pharmacy practice residency is preferred

**Travel Requirements**

- Ability to travel up to 10% of the time.

**Competencies**

- Proven leader of cross-functional teams
- Open, active and inspiring communicator (written and verbal) with professional communication style and business behavior in interactions within and outside of Daiichi Sankyo.
- Confident and influential approach, ability to provide clear instructions/guidance to teams at the same or higher levels in a global organization
- “Can do”-mentality
- Learning Agility, creativity and ability for development of new concepts
- Make independent choices and take responsibility for own actions
- Quick in the uptake of difficult and complex situations, anticipates potential problems, acts quickly / proactively and resolves them effectively
- Ability to motivate, train and lead teams in a matrix organization, understands the needs of others and creates a positive working environment
- Ability to lead in a global setting and to successfully operate across diverse cultures and geographies

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

**Salary Range:**

USD$144,800.00 - USD$217,200.00

[Download Our Benefits Summary PDF](<https://dmscdn.successfactors.com/886bee122c7aa5b9923a39bc71a2674d43c27f80448c122562765b1812b407af/static_content/1659df144cbb4da8ae09/2026_BenefitsHighlightsForPublicPosting.pdf>)

Professionals

New Jersey

Legend Biotech

Associate Director, GxP Compliance and Auditing

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking an **Associate Director, GxP Compliance and Auditing** as part of the **Global Quality** team based in **Bridgewater, NJ**.

**Role Overview**

The Associate Director, GxP Compliance and Auditing, serves as the strategic leader for the development, implementation, and continuous enhancement of Legend Biotech’s global GxP compliance and auditing programs. This role oversees all core elements of the compliance framework, including internal and externa audits, inspection readiness and logistics, supplier quality management, regulatory intelligence monitoring and dissemination, Quality Management Review oversight, and quality planning activities. Based in Bridgewater, this people-manager position oversees one direct report and is responsible for conducting internal audits at the Somerset and Raritan CARVYKTI sites, performing external third-party and supplier audits, and routinely supporting inspection readiness and related compliance activities across the Somerset and Raritan manufacturing facilities with on-site travel expected.

**Key Responsibilities**

- Lead and own global GxP compliance and auditing programs.
- Serve as the Global Business Process and System Owner for Compliance and Auditing.
- Define, implement, and maintain compliance processes, procedures, tools, and training for internal and external auditing, inspection readiness, Quality Management Review, emerging regulations, regulatory trends, and quality planning.
- Develop, implement, and continuously improve compliance processes and systems.
- Identify, implement, and maintain IT solutions that support compliance and auditing programs.
- Interpret and apply global regulations to ensure process and system compliance.
- Apply a risk-based approach to ensure areas of higher risk are visible across the organization.
- Identify and manage resource needs to support organizational growth and operational priorities.
- Drive quality metrics, risk-based methodologies, and continuous improvement initiatives.
- Establish audit trends, metrics, and quality system governance.
- Support and advise stakeholders on GxP compliance requirements.
- Partner with operational groups and network sites to foster a proactive compliance culture.
- Demonstrate alignment with Legend’s core values and behaviors.
- Ensure compliance across the organization by sustaining a level of constant inspection readiness to meet
- regulatory requirements, guidelines and industry standards.
- Drive the Inspection Readiness Program that proactively prepares the site for Health Authority/External
- Party inspections (training, pre-audit preparation, tools, hosting, close-out etc.).
- Maintain and deploy Inspection Risk Assessment Processes and Scorecards.
- Provide PAI/PLI and audit training.
- Host/support Internal Audits and host/co-host External Health Agency Inspections (Somerset and Raritan-CARVYKTI).
- Facilitate and participate in Health Authority/External Party Inspections.
- Develop and manage the response process for Health Authority and External Partner audit observations.
- Ownership of Compliance-Aligned Quality Documents (SomLead the Internal Audit Program for Somerset and Raritan-CARVYKTI to ensure compliance with Legend policies, procedures, and cGxP requirements. · Generate and execute the annual internal and external audit schedules.
- Provide management with recommendations based on internal and external audit results.
- Establish and maintain cGxP compliance audit trends and metrics.
- Manage and execute external audit programs, including vendor and third-party audits.
- Oversee external audits, vendor audits, and related audit activities.
- Oversee GxP quality audits of Legend suppliers; prepare, approve, and distribute audit reports.
- Manage audit outcomes, including CAPAs and regulatory responses.
- Perform vendor risk assessments to determine and evaluate audit frequency.
- Oversee supplier qualification, approval, and risk assessment processes.
- Execute supplier qualification activities for Somerset and Raritan-CARVYKTI.
- Develop and implement audit strategies and plans (e.g., Qualification of Apheresis Centers)
- Annual Environmental Social Governance Reporting Stewardship.
- Lead regulatory intelligence activities and monitor emerging regulations; oversee the cross-functional Regulatory Intelligence Program to identify applicable regulatory changes and establish implementation timelines and actions for Legend.
- Execute the GxP Regulatory Intelligence Program, including impact assessments, maintenance, routine dissemination to stakeholders, publication, and intranet site maintenance for Somerset and Raritan-CARVYKTI.
- Oversee and execute the Quality Systems Management Review Program (QSMR), working cross functionally to identify key quality metrics that monitor product quality, quality systems, compliance sustainability and drive continuous improvement and actions.
- Drive/coordinate Quality Planning.
- Build cross-functional partnerships to strengthen compliance culture.
- Provide QA advice to stakeholders (e.g., manufacturing, CROs, CMOs) based on analyses and interpretation of cGxP regulations.
- Establish key stakeholder relationships with Global and Site Quality functions, Manufacturing operations and Suppliers.
- Ability to interact and influence all levels within the organization to achieve compliance.
- Maintain cGxP related quality system SOPs in compliance with all applicable regulatory requirements to align with existing company policies.
- Ownership of Compliance-Aligned Quality Documents at Bridgewater and Somerset.
- Support Annual Environmental Social Governance Reporting activities.

**Requirements**

- Bachelor’s degree in a scientific or technical discipline required (e.g., Life Sciences, Engineering, Pharmacy, or related scientific/technical discipline). Advanced degree (MS, MBA, PhD) preferred.
- Minimum 12 years of relevant GxP work experience in Quality, Quality Compliance, Regulatory, or related functions within the biopharmaceutical or advanced therapies industry. Minimum 5 years of leadership experience, including senior-level project planning and execution. Demonstrated success leading through influence in a matrixed organization; experience managing direct reports is beneficial but not required for this role. Proven experience conducting internal audits, hosting external audits, and supporting global health authority inspections. Experience implementing global processes and driving cross-site alignment. Experience hosting regulatory inspections and leading enterprise-level compliance programs. Experience in aseptic manufacturing facility, biologics, or advance therapies strongly preferred, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. Experience working across all GxP functions (GMP, GDP, GCP, GLP) preferred.
- 20% travel is required.
- Knowledge of GxP requirements for quality systems and processes that enable compliance.
- Deep expertise in global GxP regulations and quality compliance frameworks, including: o 21 CFR, ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA, China GMP Regulations.
- Experience conducting internal audits and self-inspections, including writing audit reports, issuing observations, and ensuring follow-through to closure.
- Experience in Regulatory Intelligence mining.
- Experience hosting front-room/back-room activities for external audits and global agency inspections.
- Ability to interpret evolving regulations and apply them to processes, systems, and quality governance.
- Strong strategic thinking, risk-based decision-making, and data-driven analysis.
- Proven experience implementing global processes and driving cross-site harmonization.
- Ability to anticipate compliance risks and proactively strengthen systems and controls.
- Demonstrated ability to lead complex programs and quality initiatives across multiple sites.
- Ability to provide clear direction and influence individuals across all levels of the organization.
- Proven ability to influence across all levels of the organization without direct authority.
- Strong written and verbal communication skills.
- Effective interpersonal skills with the ability to collaborate across functions and geographies.
- Proven analytical problem-solving and conflict-resolution skills.
- Ability to work independently with a high degree of accountability and sound judgment.
- IT system development lifecycle knowledge (requirements gathering, change management, testing, implementation, continuous improvement).
- Experience defining key quality metrics, reporting metrics, analyzing trends, and applying process improvement techniques.
- Operational experience with electronic quality systems and digital compliance tools.
- Proficiency with Microsoft Office applications (Outlook, Excel, Word, PowerPoint).
- Highly organized, agile, and able to manage shifting priorities in a fast-paced, dynamic environment.
- Flexible, highly motivated, with strong organizational skills and the ability to multitask with attention to detail.
- Must be able to manage critical deadlines and competing priorities effectively.
- Effective time-management skills and ability to drive results independently.
- Demonstrated alignment with Legend’s core values: Patient First, Innovation, OneTeam, Results Driven, Integrity.
- Demonstrated alignment with Legend’s core behaviors: Ownership & Commitment, Agility & Prioritization, Teamwork & Communication, Continuous Improvement.

\#Li-BZ1

\#Li-Hybrid

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay):

$168,372 - $220,988 USD

**Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.**

**Work Authorization & Employment Eligibility**

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

**EEO Statement**

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

For information related to our privacy notice, please review: [Legend Biotech Privacy Notice](<https://legendbiotech.com/privacy-notice/>).

Director, Regulatory CMC

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking a **Director, Regulatory CMC** as part of the **Regulatory Affairs** team based in **Somerset, NJ.**

**Key Responsibilities**

- Develop, lead, and execute global CMC regulatory strategies across commercial products and development- stage programs, with primary accountability for late-stage development and post-approval lifecycle management activities.
- Provide strategic regulatory leadership to cross-functional teams, influencing development and manufacturing strategies, identifying regulatory risks and opportunities, and driving effective mitigation and contingency plans to support program objectives.
- Serve as the primary Regulatory CMC representative on cross-functional program teams and governance committees, ensuring alignment of regulatory strategies with corporate and portfolio goals.
- Lead and coordinate regulatory CMC planning, preparation of submissions, and interaction with Health Authorities.
- Establish and maintain strong partnerships with internal stakeholders and external collaborators to ensure effective execution of regulatory objectives.
- Drive continuous improvement initiatives within the Regulatory CMC function, including development of regulatory processes, best practices, and knowledge management to enhance organizational effectiveness and compliance.
- Guide and support junior staff as applicable.

**Requirements**

- Advanced degree in life sciences, biotechnology, pharmaceutical sciences, engineering, or related discipline.
- 10+ years of biotechnology or pharmaceutical industry experience.
- 7+ years of Regulatory CMC experience supporting biologics, cell and gene therapy. Direct experience with CAR-T cell therapies is desired.
- Strong CMC technical background is required. Ability to critically evaluate data from a broad range of scientific disciplines.
- Demonstrated experience leading late-stage programs and post-approval Regulatory CMC experience supporting commercial products, including lifecycle management, supplements, variations, annual reports, and post-approval commitments.
- Demonstrated global CMC regulatory experience.
- Deep understanding of global CMC requirements on cell and gene therapy.
- Expertise in late-stage development and lifecycle management.
- Strong leadership, strategic thinking, communication, and technical writing skills.
- Ability to manage multiple programs.

\#Li-AS1

\#Li-Hybrid

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay):

$193,629 - $254,137 USD

**Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.**

**Work Authorization & Employment Eligibility**

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

**EEO Statement**

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

For information related to our privacy notice, please review: [Legend Biotech Privacy Notice](<https://legendbiotech.com/privacy-notice/>).

Sr. Manager, Regulatory CMC

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking a **Sr. Manager, Regulatory CMC** as part of the **Regulatory Affairs** team based in **Somerset, NJ.**

**Role Overview**

This position will support the development and execution of global CMC regulatory strategies for pipeline programs, with a strong focus on regulatory dossier authoring and cross-functional collaboration to advance product development milestones.

**Key Responsibilities**

- Support the development and execution of global CMC regulatory strategies for pipeline cell and gene therapy programs, including CAR-T and lentiviral vector products.
- Partner closely with Regulatory CMC Program Leads and cross-functional subject matter experts to plan, prepare, review, and coordinate CMC components of global regulatory submissions, including INDs, CTAs, BLAs, MAAs, amendments, supplements, and responses to Health Authority requests.
- Author, review, and maintain high-quality CMC regulatory documentation to support global development, registration, and commercialization activities, ensuring compliance with applicable regulatory requirements and company standards.
- Collaborate with cross-functional technical teams, including Process Development, Manufacturing,
- Analytical Development, and Quality, to understand complex CMC information and effectively translate it into clear, scientifically sound regulatory submissions.
- Evaluate and interpret technical documentation, including development reports, validation protocols and reports, comparability assessments, and manufacturing change packages, to support regulatory impact assessments, submission strategies, and regulatory decision-making.

**Requirements**

- Bachelor's degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, Biochemistry, Chemistry, Engineering, or related discipline required. Advanced degree (MS, PhD, PharmD) preferred.
- 5+ years of biotechnology or pharmaceutical industry experience with strong technical background.
- Minimum of 1-2 years of Regulatory CMC experience supporting biologics, cell and gene therapy products, or extensive experience authoring and managing CMC sections of regulatory dossiers and submissions.
- Experience working with process development, analytical development, or manufacturing teams.
- Experience supporting cell and gene therapies highly preferred.
- Familiarity with global regulatory requirements, including FDA, EMA, and ICH guidelines.
- Strong scientific understanding and technical background on biologics or cell and gene therapy products.
- Excellent technical writing and document preparation skills with demonstrated experience authoring regulatory submission content.
- Ability to critically review and interpret scientific and technical data and translate complex information into clear regulatory documentation.
- Strong project management and organizational skills.
- Ability to manage multiple programs and competing priorities in a fast-paced environment.
- Strong communication and collaboration skills with cross-functional stakeholders.

\#Li-JR1

\#Li-Hybrid

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay):

$146,410 - $192,164 USD

**Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.**

**Work Authorization & Employment Eligibility**

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

**EEO Statement**

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

For information related to our privacy notice, please review: [Legend Biotech Privacy Notice](<https://legendbiotech.com/privacy-notice/>).

Patent Counsel/Senior Patent Counsel

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking a **Patent Counsel/Senior Patent Counsel** as part of the **Legal** team based in either **Philadelphia, PA or Somerset, NJ.**

**Role Overview**

Legend Biotech’s Intellectual Property team is seeking a Patent Counsel/ Senior Patent Counsel with large molecule expertise, including antibody and process development experience. Experience in cell and gene

therapy and gene therapy platforms is a plus. As a partner and business strategist, this individual contributor will push the boundaries of what is possible in a highly competitive industry. This position reports directly to the Global Head of Intellectual Property in Legend’s Legal Department. Come join our passion for creating IP strategies that will enable Legend to improve the lives of patients worldwide. This is a hybrid position (currently 3 days a week). There is expected to be some travel between Legend Headquarters in Bridgewater NJ and Legend’s R&D locations in Philadelphia PA and Somerset, NJ.

**Key Responsibilities**

- Driving strategic IP procurement and management of global intellectual property, including drafting and prosecuting patent portfolios, working with outside counsel, and serving as a key legal partner on
  business development, licensing, collaboration, acquisition, and other strategic transactions.
- Responsibilities include supporting IP-focused due diligence, evaluating transaction-related risks and opportunities, advising on intellectual property strategy, and conducting freedom-to-operate,
  infringement, validity, and risk assessment and mitigation analyses.
- Managing the prosecution of active global dockets, including handling U.S. and foreign patent applications as well as post-grant proceedings (e.g., reexamination, reissue, post-grant review. foreign
  oppositions and appeals), as necessary.
- Rendering due diligence assessments, freedom-to-operate, infringement, and validity analyses, and risk evaluation and mitigation strategies.
- Identifying and exploiting new strategic opportunities and approaches by leveraging a deep understanding of patent law and a knowledge of the competitive landscape.
- Partnering effectively with relevant stakeholders at all levels and of the global Legend organization and across all phases of research, development, and commercialization to provide clear, strategic business enabling strategies.
- Influencing business leaders as a trusted advisor and thought partner.
- Deploying in-depth patent and scientific expertise to provide education, guidance, and advice on patent law issues to scientists conducting research and other business stakeholders.
- Maintaining and sharing expertise and knowledge on legal case law, rules, or regulations before the
- U.S. Patent and Trademark Office as well as other relevant jurisdictional IP offices.
- Reviewing, drafting, and negotiating intellectual property provisions in a broad range of commercial, research, development, manufacturing, collaboration, licensing, and other corporate agreements to ensure alignment with Legend's intellectual property strategy and business objectives.
- Supporting business development, licensing, collaboration, and other strategic transactions by conducting IP diligence, assessing intellectual property assets and risks, and advising on transaction structure and intellectual property strategy.
- Partnering in intellectual property-related transactions, adverse proceedings, and litigation activities related to individual's program responsibilities.
- Participating in group, department, and cross-functional projects and initiatives where strategies, processes, operating standards, and/or practices are developed and deployed to ensure highest quality practices and execution for all aspects of IP portfolios in a high performing, agile team setting.
- Sustainably building enduring, productive external relationships with outside counsel, third-party collaborators, and partners.

**Requirements**

- Minimum requirements: Undergraduate degree in the biological sciences with focus on immunology, cell biology, cancer biology, biochemistry, and the like. Preference given to those with advanced degrees. Admission to practice before the U.S. Patent and Trademark Office (USPTO) required. U.S. law degree (J.D.)
- 8+ years of patent attorney experience in life sciences patent prosecution, with majority of experience in patent application drafting and prosecution in a pharma/biotech corporate
  setting and/or representing such clients/matters in a law firm.
- Admission to practice before the U.S. Patent and Trademark Office (USPTO) required.
- A current “good standing” admission to at least one U.S. state bar is required.
- Building and leveraging global IP portfolios for biopharmaceuticals at all stages of prosecution and enforcement;
- Designing and executing complex freedom-to-operate analyses across different technologies and different jurisdictions.
- Developing and communicating actionable risk mitigation strategies;
- Experience supporting business development, licensing, collaboration, and other strategic transactions, including intellectual property due diligence, risk assessment, and negotiation of intellectual property-related agreement provisions, is preferred.
- Experience in adverse IP proceedings, including but not limited to US litigation, is a plus.
- Experience in gene therapy, cell therapy, and RNA therapeutics is a plus.
- Exhibits poise under pressure, solution-oriented mindset, clear communication at all levels of an organization, effective collaboration across local and global teams, and active in-person presence with IP/Legal and business stakeholders.
- Tackles new challenges with curiosity and a growth-mindset, effectively utilizing available resources, and an enthusiastic willingness to listen and learn from
  others.
- Excels in working independently and proactively with minimal direction, strong organizational skills, and ability to prioritize and balance competing projects and responsibilities in a fast-paced global organization.
- Must have a demonstrated capacity to manage and prioritize multiple tasks and to work efficiently and independently in a deadline-driven, high-volume.
- Must be highly detail-oriented and have excellent oral and written communications skills.
- Must possess strong computer skills, including knowledge of databases and spreadsheets and proficiency with Microsoft Office (Word, Excel, PowerPoint, and
  Outlook).
- Must have strong interpersonal skills, time management, organization, prioritization, planning and coordination, and multi-tasking skills.
- Must demonstrate an ability to build relationships and work as a team player.
- Must be able to maintain the integrity of confidential and sensitive information in a professional manner.
- Embraces a growth-mindset and enjoys working in a fast-paced and diverse global organization.
- Engages actively in Group, Department, and cross-functional projects and initiatives where strategies, processes, operating standards and/or practices are developed and deployed, to ensure the highest quality IP portfolios in a high performing, agile team setting.
- Embraces and fosters a team and organizational culture that reflects a commitment to diversity, equity, and inclusion.
- Organization, attention to detail, and analytical abilities.
- Proactive, self-disciplined and able to work independently with minimal supervision.

\#Li-FB1

\#Li-Hybrid

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay):

$168,372 - $220,988 USD

**Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.**

**Work Authorization & Employment Eligibility**

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

**EEO Statement**

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

For information related to our privacy notice, please review: [Legend Biotech Privacy Notice](<https://legendbiotech.com/privacy-notice/>).

Novo Nordisk

Senior GxP Compliance & Patient Safety Technical Writing Manager

**About the Department**

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?

**The Position**

Develops procedural documentation in a GxP environment, ensuring compliance and operational effectiveness, while also creating and writing content for training materials and developing job aids. Conducts electronic document management system (EDMS) administration through the routing of documents for review and approval workflows, managing periodic review cycles and maintaining accurate document metadata. Supports activities related to deviations and corrective actions impacting relevant processes. Supports and maintains inspection readiness for the GxP Compliance and Patient Safety Training team.

**Relationship**

This job reports to the Director of GxP Compliance & Patient Safety Training. This job will interact with Patient Safety, Quality, Vendor and Contract Management, IT, Finance, Contract/Supplier of Customer Engagement Programs and other CMR Functional areas.

**Essential Functions**

- SME for writing and updating standard operating procedures (SOPs) and supporting documents
- Execute routine workflows for document management systems, such as QualityDocs
- Support ongoing inspection readiness efforts and provide support during audits
- Assists in the closure of CAPAs, deviations and other quality activities
- Key Area #1: Process & Document Creation
  - Develop and maintain procedures and supporting documents (e.g., SOPs, work instructions and job aids), incorporating input from Patient Safety leadership and relevant Subject Matter Experts (SMEs)
  - Ensure GxP processes and related documentation adhere to regulatory requirements, support corporate compliance and are inspection ready
  - Create and write supporting content for training programs, including user-friendly job aids that support process understanding and application
  - Support the development and maintenance of GxP process flows
- Key Area #2: System Administration
  - Execute routine workflows for electronic document management via VeevaVault QualityDocs
  - Prepare documents for review and approval workflows in QualityDocs, ensuring an audit trail is maintained, and electronic signatures are received from relevant stakeholders on time
  - Execute routine GxP document maintenance through periodic review cycles
- Key Area #3: Inspection Readiness & Audit Support
  - Support compliance and audit/inspection readiness strategies and plans, ensuring all documentation meets necessary standards
  - Ensure controlled documentation (including vendor training procedures and records) is accurately maintained, versioned and audit ready
  - Provide validated reports from QualityDocs, when requested, in support of audits and inspections

**Physical Requirements**

Approximately 10% overnight travel.

**Qualifications**

- A bachelor’s degree in Communications, Medical or Science-related discipline required; relevant experience may be substituted for degree
- 7+ years progressive responsibility experience in relevant pharmaceutical industry
- Experience in process development, delivery and/or implementation is preferred, including the creation of training content and job aids
- GxP environment experience required; pharmacovigilance (PV) experience preferred, with knowledge of medical terminology
- Excellent presentation, interpersonal and stakeholder management and coaching skills and demonstrated ability to collaborate with cross-functional stakeholders
- High proficiency in PowerPoint, Word, Outlook and Excel
- High proficiency in AI and other documentation software and platforms
- Demonstrated skills in Visio and other flowchart software
- Strong project management skills with abilities to manage multiple projects

The base compensation range for this position is $120,300 to $185,000. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.

Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy and parental leave policy.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

GRAIL Inc

Senior Process Engineer - Compliance #4968

Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.

We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.

GRAIL is headquartered in the Bay Area of California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies.

For more information, please visit [grail.com](<http://grail.com/>)

The Senior Process Engineer leads complex investigations, compliance related initiatives and supports document management processes. This role is primarily responsible for driving quality management system (QMS) activities across engineering, validation, clinical laboratory and operations, including change control management, SOP lifecycle oversight, nonconformance (NC) and CAPA metrics management, training compliance, and continuous process improvement. The Senior Process Engineer works across functions to design and implement process improvements, serve as a technical resource to peers and technicians, and ensure compliance with regulatory and quality requirements.

In addition, this role provides advanced technical expertise in high-complexity molecular diagnostic workflows supporting the Galleri® assay and collaborates cross-functionally to ensure operational excellence, regulatory readiness, and sustained compliance with applicable regulatory and accreditation requirements.

This position works full time onsite in Durham, NC.

**Responsibilities:**

- Lead and own quality management system (QMS) activities, including change controls, document control, SOP revisions, deviations/nonconformances (NCs), and corrective and preventive actions (CAPAs).
- Develop and maintain work instructions, guidelines, verifications, and standard operating procedures.
- Independently investigate and resolve process deviations, applying root cause analysis and implementing effective corrective and preventive actions.
- Support internal audits, external inspections, and regulatory assessments; prepare documentation, evidence packages, and responses to audit observations.
- Partner cross-functionally with Quality Assurance, Regulatory Affairs, Engineering Operations, Validation, and Clinical Operations leadership to implement and sustain compliant processes.
- Identify process gaps, compliance risks, and operational inefficiencies; recommend and implement sustainable corrective actions and process improvements.
- Mentor and train personnel on workflows, quality processes, and regulatory expectations.
- Provide technical guidance and support to engineers and technicians to promote process understanding and standardization.
- Prepare and present technical reports, proposals, and recommendations to management for process enhancements and cost savings.
- Develop training compliance processes, including assignment, completion tracking, and on the job training assessments.
- These job duties are a summary of the primary duties and responsibilities of the job and position. It is not intended to be a comprehensive or all-inclusive listing of duties and responsibilities. Contents are subject to change at the company's discretion.

**Required Qualifications:**

- Bachelor’s degree in Engineering (Chemical, Mechanical, Industrial, or related field) with 5+ years of relevant experience, or Master’s degree with 3+ years of relevant experience, or PhD with 2+ years of relevant experience.
- Demonstrated level of knowledge regarding applicable regulatory standards commensurate with the position's complexity and scope, contributing to organizational regulatory compliance. Minimal applicable standards for this position include:
  - GMP quality management systems (e.g. ISO 13485)
  - Clinical laboratory regulations (e.g. CAP, CLIA, NYSDOH, ISO 15189)
  - Operations within the regulated medical device environment (e.g. IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11)
- Experience supporting audits, inspections, and regulatory readiness activities.
- Proven ability to manage multiple priorities and drive projects to completion in a fast-paced regulated environment.

**Preferred Qualifications:**

- Strong working knowledge of quality management systems (QMS) and regulated laboratory/manufacturing operations.
- Expertise in change control, CAPA management, deviation/nonconformance investigations, and document control processes.
- Strong analytical and organizational skills with the ability to manage metrics, trend data, and compliance reporting.
- Excellent written and verbal communication skills, including technical writing and audit documentation.
- Strong collaboration and stakeholder management skills across cross-functional teams.
- Process improvement mindset with demonstrated success driving operational and quality improvements.
- Experience in executing within computerized maintenance/calibration equipment management systems.
- Excellent communication skills to influence and collaborate across departments and present technical findings.
- Leadership skills to mentor junior engineers and lead cross-functional teams.
- Strong project management and organizational skills; able to manage multiple workstreams with competing priorities

**Physical Demands and Work Environment:**

- Work performed in office, laboratory, and manufacturing production environments.
- Regular interaction with production equipment, requiring PPE such as safety glasses, gloves, lab coats, or cleanroom garments.
- Frequent standing, walking, and occasional lifting of 25–30 lbs.
- Exposure to chemicals, noise, and temperature variations in production areas.
- May require flexible hours, overtime, or weekend work to support production or project deadlines.

The expected, full-time, annual base pay scale for this position is $95k-$125k.

At GRAIL, we believe in recognizing and rewarding the contributions our employees make to our mission and success. In addition to base pay, this role may be eligible for additional compensation, including an annual bonus and/or other incentives, in accordance with applicable plans and the company's discretion. The posted range reflects our good-faith estimate of the base pay we expect to offer for this position at the time of hire. Actual compensation will be determined based on factors such as the candidate’s experience, skills, qualifications, and other relevant considerations.

At GRAIL, we invest in the health, well-being, and future of our employees and their families. Employees in this role are eligible for a comprehensive and competitive benefits package designed to support what matters most, including flexible time off or vacation, a 401(k) retirement plan with employer match, medical, dental, and vision coverage, and thoughtfully selected well-being programs. Benefits are offered in accordance with applicable plans and policies.

GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, disability, status as a protected veteran, or any other class or characteristic protected by applicable federal, state, and local laws. Additionally, GRAIL will consider for employment qualified applicants with arrest and conviction records in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities. Please contact us at \[email protected\] if you require an accommodation to apply for an open position.

GRAIL maintains a drug-free workplace. We welcome job-seekers from all backgrounds to join us!

Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

North Carolina

GenScript

Research Associate

**About GenScript**

Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Guided by its mission to Make People and Nature Healthier Through Biotechnology, and its role as a well-recognized biotechnology company, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions.

GenScript is looking for a highly motivated and scientifically rigorous individual to join our RNA team for RNA delivery formulation and new RNA product research and development as Research Associate. This position will focus on developing novel lipid nanoparticle formulations for RNA delivery.

**Responsibilities:**

- Prepare formulations and perform characterization assays, data analysis.
- Support developing assays for formulation characterization in vitro.
- Contribute in the development, writing and reviewing analytical method protocols.
- Prepare technical reports and presentations for clear communication of scientific findings in the team.
- Monitors supply inventory and identify any products required.
- Maintains work area, equipment, department and all storage areas in a clean, neat and orderly manner.
- Perform other duties as needed.

**Requirements:**

- Bachelor's degree in molecular biology, chemistry, biochemistry, pharmaceutical science, chemical engineering or related field, Master is preferred
- 0-5 years of relevant experience in nucleic acid delivery with hands-on experience in lipid nanoparticle formulation and characterization
- Direct experience with messenger RNA is preferred
- Understanding and success in implementation of RNA-related analytics (ribogreen, gel electrophoresis, capillary electrophoresis, etc) is preferred
- Works collaboratively with team members to support each other
- Excellent communication and problem-solving skills
- A sense of humility and an eagerness to continue to learn and contribute to a supportive team

**Benefit:**

- Medical Insurance/ Vision Insurance/ Dental Insurance
- 401(k) & Retirement Savings Plan (RSP)
- Short Term Disability Insurance
- New Child Leave
- Paid Time Off
- Paid Company Holidays per year
- Paid Sick Days (earned based on hours worked)
- Compassionate Leave
- Jury Duty Leave
- Float day
- Personal days

**Perks:**

- Free colleague meals during shift
- Onsite massages Charis
- Onsite gyms

**Compensation:**

Salary range: $75,000 – $90,000 total compensation, including bonus, depending on experience and qualifications.

**Benefits:**

Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.

Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Washington

Dyne Therapeutics

Associate Director, Regulatory Operations - Veeva Vault RIM

**Company Overview:**

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at [https://www.dyne-tx.com/](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DaBhdU0rLyxqDF5MLc_hIfw7usSG4P5AlGZUt689alyH6v7mzOmFdpd9s5X8DlnvZSiEkR5UEisX91xRDuQTa2VgG02ByJmFzR8fXOPz8Zi8%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825271389%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=J6tnBKJnocuFhoQSNnLD03mlmX8CCP4Ufz89Tz2BRqY%3D&reserved=0>), and follow us on [X](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DLBKooGRVe4UrE2Sa6ReueOswzx2nXn5X8MuiTcNNQ_6lX0cFP8Xf24jpFASx3QmF9Qt-1g3RGsigqX34LIiwMg%3D%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825316922%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=1SaJTlzgJLAz3INco8zVJpHByglVu9H3uR4eaUUwqbY%3D&reserved=0>), [LinkedIn](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DV9e03kLdDWSbh0_VwnuvS9iTb21RRXsSKiAaMEbducMXKsrR2S-Gw7FLuap5gHCzvcaUIvGPyAeg1wRzFGrqW9J_Z6Ha8bGtJaWV9voKp-c%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825339609%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=bDmOn9uD5vB9%2F2LttEyLg%2BANoH6v3vDFv7SAwVdi%2BoI%3D&reserved=0>) and [Facebook](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DCMyzCcuOkxGNqTNEki-upZwJJPBCJLp0a-MvjKwwfPo1XQp8XutL02Vy2Vg3ZmpnCYnPLhHxcgEzFeh-07gg_rWzXbiw64-AClVkXbKyKQs%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825359448%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=exQuTFG7FGBX1V0XPy4zSebLvhQUDksB19Nej8Eg3DQ%3D&reserved=0>).

**Role Summary:**

The Associate Director, Regulatory Operations – Veeva Vault RIM is a key member of the Regulatory Operations team responsible for the business ownership, administration, governance, optimization, and ongoing evolution of Dyne’s Regulatory Information Management capabilities. This role serves as the primary subject matter expert for Veeva Vault RIM and partners with Regulatory Affairs, Quality, Information Technology, Clinical, CMC, Pharmacovigilance, vendors, and other stakeholders to ensure regulatory information, processes, and systems are accurate, compliant, scalable, and inspection ready.

This role translates regulatory and business needs into practical system solutions, establishes effective data and process governance, leads system enhancements and release readiness, and drives consistent adoption through clear standards, documentation, training, and user support. This individual will balance strategic planning with hands-on execution and will play an important role in building the regulatory infrastructure needed to support Dyne’s growing pipeline, global submissions, health authority interactions, and future commercialization.

This role is fully remote.

**Primary Responsibilities Include:**

*Veeva Vault RIM Business Ownership & Strategy*

- Serve as the business owner and primary subject matter expert for Dyne’s Veeva Vault RIM platform, including applicable capabilities supporting Registrations, Submissions, Submissions Archive, Publishing, Health Authority Interactions, Regulatory Objectives, commitments, reporting, and system administration
- Define and maintain a scalable RIM operating model, governance framework, enhancement roadmap, and system standards aligned with regulatory priorities, business needs, data integrity expectations, and the evolving needs of Dyne’s pipeline
- Partner with Regulatory Affairs leadership, Information Technology, Quality, system administrators, vendors, and business stakeholders to prioritize system capabilities, enhancements, integrations, and continuous improvement opportunities
- Translate regulatory strategy, operational requirements, and user needs into clear business requirements, functional specifications, user stories, workflows, configuration decisions, and implementation plans
- Evaluate new Veeva releases, functionality, automation opportunities, and industry capabilities and recommend solutions that improve efficiency, compliance, usability, scalability, and regulatory decision-making
- Maintain a strong understanding of the Veeva Vault RIM data model, object relationships, workflows, metadata, security, reporting capabilities, and module interdependencies

*Regulatory Operations, Submissions & Health Authority Support*

- Partner with Regulatory Affairs leads and cross-functional teams to translate global regulatory strategies into clear operational plans, milestones, submission activities, and system requirements
- Support submission planning, content planning, tracking, and execution across development programs and regions, including INDs, CTAs, amendments, annual reports, briefing packages, marketing applications, and other regulatory filings as applicable
- Establish and maintain fit-for-purpose processes for regulatory submissions, registrations, health authority correspondence, questions, commitments, regulatory objectives, and related records
- Ensure health authority interactions, questions, responses, decisions, commitments, and key regulatory milestones are accurately captured, linked, maintained, and readily available within the RIM environment
- Partner with Regulatory Operations colleagues and external vendors to support technically compliant, timely, and high-quality submissions and archival activities
- Develop and maintain portfolio-level visibility into submission plans, milestones, dependencies, status, risks, and health authority commitments
- Identify operational risks, process gaps, and system constraints that may affect regulatory deliverables and collaborate with stakeholders to develop practical mitigation plans
- Support regulatory inspection, audit, and due diligence readiness by ensuring regulatory records and supporting documentation are complete, accurate, traceable, and accessible

*System Configuration, Administration & Lifecycle Management*

- Lead or perform business configuration of Veeva Vault RIM, including users, roles, permissions, metadata, document types, object configurations, workflows, lifecycles, picklists, notifications, reports, and dashboards
- Establish and maintain role-based access, security, and segregation-of-duties controls in partnership with Information Technology, Quality, and functional owners
- Manage the intake, assessment, prioritization, documentation, testing, implementation, and communication of system changes, enhancements, and defect resolutions
- Lead business readiness for Veeva releases and system upgrades, including impact assessments, release planning, regression testing, user acceptance testing, communications, training, and post-implementation support
- Coordinate with technical teams and vendors on integrations, data exchanges, migration activities, system performance, issue resolution, and ongoing platform support
- Maintain system inventories, configuration documentation, traceability records, decision logs, issue logs, enhancement backlogs, and release documentation
- Apply structured change management practices to support successful implementation and sustained adoption of new system capabilities and processes

*Regulatory Data Governance, Quality & Reporting*

- Establish and maintain regulatory data standards, naming conventions, controlled vocabularies, metadata definitions, stewardship responsibilities, and business rules across the RIM environment
- Drive the completeness, consistency, accuracy, timeliness, and traceability of regulatory data and documents across products, applications, registrations, submissions, health authority interactions, objectives, and commitments
- Define and monitor data quality controls, exception reports, reconciliations, and remediation activities to identify and address data integrity risks
- Partner with Regulatory Affairs, CMC, Quality, Clinical, Pharmacovigilance, Enterprise Data, and Information Technology stakeholders to align regulatory information across systems and processes
- Develop, maintain, and continuously improve dashboards, reports, and analytics that provide visibility into submission status, health authority communications, commitments, system adoption, data quality, compliance, cycle times, and operational performance
- Translate RIM data into clear insights, trends, risks, and recommendations that support regulatory planning, prioritization, leadership decisions, and continuous improvement
- Maintain awareness of evolving regulatory data standards and requirements, including IDMP, xEVMPD, structured data, and other global regulatory information initiatives, and assess implications for Dyne’s processes and systems

*Compliance, Validation & Inspection Readiness*

- Ensure Veeva Vault RIM processes, configurations, documentation, and controls comply with applicable GxP requirements, regulatory expectations, company policies, data integrity principles, and validated-system procedures
- Partner with Quality and Information Technology to define and execute a risk-based computer system validation and change-control approach for new capabilities, configurations, integrations, upgrades, and enhancements
- Lead or support validation deliverables, including requirements, risk assessments, test plans, test scripts, traceability, deviations, summary reports, and approval documentation
- Maintain oversight of audit trails, periodic reviews, access reviews, system issues, deviations, corrective and preventive actions, and other compliance-related activities
- Serve as the Regulatory Operations system representative during audits, inspections, due diligence activities, and internal compliance reviews
- Proactively identify compliance and inspection-readiness risks and lead remediation plans in partnership with appropriate stakeholders
- Ensure system and process documentation remains current, approved, controlled, and aligned with actual business practices

*Process Excellence, Documentation & User Enablement*

- Lead the design, harmonization, documentation, and continuous improvement of regulatory operations processes across programs, functions, and regions
- Develop and maintain policies, standard operating procedures, work instructions, process maps, job aids, templates, governance documents, and system administration guides
- Apply a user-centered and risk-based approach to simplify workflows, reduce manual effort, improve cycle times, increase data quality, and strengthen operational consistency
- Develop and execute role-based training, onboarding, refresher training, office hours, and communication plans that build user capability and drive consistent adoption
- Establish a sustainable support model for user questions, access requests, issue triage, escalation, resolution, and knowledge management
- Gather and analyze user feedback, system usage, support trends, and performance data to identify opportunities to improve the user experience and business outcomes
- Promote effective use of Veeva Vault RIM and reinforce accountability for regulatory data ownership, process adherence, and documentation quality

*Cross-Functional Leadership & Vendor Management*

- Serve as a trusted partner to Regulatory Affairs, Regulatory Operations, CMC, Quality, Clinical Development, Clinical Operations, Pharmacovigilance, Medical Writing, Information Technology, Program Management, and other stakeholders
- Lead cross-functional workstreams and projects involving regulatory systems, data, processes, integrations, submissions, and operational readiness
- Facilitate requirements workshops, design discussions, governance forums, status reviews, decision-making sessions, and issue-resolution meetings
- Communicate system strategy, priorities, progress, risks, dependencies, tradeoffs, and recommendations clearly to functional leaders, project teams, and senior stakeholders
- Manage vendor and consultant activities, including scope, timelines, deliverables, quality, issue resolution, knowledge transfer, and performance oversight
- Influence outcomes without direct authority and build alignment across technical and nontechnical stakeholders with differing priorities
- Provide guidance, coaching, and subject matter expertise to system administrators, contractors, regulatory colleagues, and end users
- Model Dyne’s values and foster a culture of accountability, collaboration, integrity, quality, urgency, and continuous improvement

**Education and Skills Requirements:**

- Bachelor’s degree in life sciences, information systems, computer science, regulatory affairs, or a related discipline required; advanced degree preferred
- 8+ years of relevant experience in Regulatory Operations, Regulatory Information Management, regulatory systems, regulatory data management, or a related discipline within the pharmaceutical or biotechnology industry
- 5+ years of direct, hands-on experience with Veeva Vault RIM in a business owner, functional lead, product owner, system administrator, business analyst, or comparable role
- Deep working knowledge of Veeva Vault RIM capabilities, including Registrations, Submissions, Submissions Archive, Publishing, Health Authority Interactions, Regulatory Objectives, commitments, reporting, workflows, metadata, lifecycles, user access, and object security
- Demonstrated experience translating regulatory and business requirements into scalable system configurations, workflows, data standards, reports, and operational solutions
- Strong understanding of global regulatory operations, drug development processes, regulatory submission pathways, regulatory content management, registration management, health authority interactions, and product lifecycle activities
- Experience supporting global regulatory submissions and associated planning, tracking, document management, publishing, archival, and compliance activities
- Demonstrated knowledge of GxP requirements, computer system validation, 21 CFR Part 11, data integrity principles, audit trails, electronic records, change control, and inspection-readiness expectations
- Experience leading Veeva releases, system enhancements, user acceptance testing, validation activities, data migration, system implementation, or integration initiatives
- Experience establishing or improving regulatory data governance, metadata standards, controlled vocabularies, data-quality controls, stewardship models, and reporting practices
- Familiarity with regulatory data standards and initiatives such as IDMP, xEVMPD, structured content planning, and structured regulatory data preferred
- Experience developing dashboards, metrics, reports, and operational insights using Veeva reporting capabilities, Microsoft Excel, Power BI, Tableau, or similar tools preferred
- Demonstrated ability to develop clear policies, standard operating procedures, work instructions, process maps, business requirements, functional specifications, test scripts, training materials, and system documentation
- Strong project and program management skills, with the ability to plan and lead complex cross-functional initiatives, manage dependencies, identify risks, resolve issues, and deliver high-quality outcomes against firm timelines
- Proven ability to lead through influence, build alignment, and collaborate effectively across Regulatory Affairs, Quality, Information Technology, Clinical, CMC, Pharmacovigilance, vendors, and other functional partners
- Strong analytical, critical-thinking, and problem-solving skills, with the ability to evaluate complex processes and data and translate findings into practical recommendations
- Excellent written, verbal, facilitation, and presentation skills, with the ability to communicate technical and regulatory concepts clearly to diverse audiences
- Strong attention to detail and demonstrated commitment to data integrity, compliance, documentation quality, operational excellence, and inspection readiness
- Ability to balance strategic planning with hands-on execution and operate with independence, sound judgment, accountability, urgency, and flexibility in a growing biotechnology company
- Demonstrated ability to manage multiple priorities and adapt effectively in a fast-paced, matrixed environment with evolving business and regulatory needs
- Veeva Vault Administrator certification or other relevant Veeva certification strongly preferred
- Experience in rare disease, neuromuscular disease, genetic medicine, oligonucleotide therapeutics, or a clinical-stage biotechnology environment preferred
- Experience managing vendors, consultants, contractors, or external service providers preferred
- Ability to travel as needed for internal meetings, vendor engagements, training, audits, or other business activities

\#LI-Onsite

MA Pay Range

$160,000 - $195,000 USD

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

*Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.*

Nationwide

Associate Director, US Medical Research & Strategy

Job Description

Job Title: Associate Director, US Medical Research & Strategy

Job Requisition ID: 2196

Posting Start Date: 10/6/26

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

**Job Summary**

The Associate Director will provide program management support across all the Medical Affairs functions that are working on a launch, approved products or earlier assets to assure consistent planning, execution, tracking and reporting of activities in accordance with Medical Affairs strategy and objectives. This includes assuring appropriate planning, execution, tracking and reporting activities with cross-functional partners and if applicable, Alliance counterparts.

**Responsibilities**

Partners with US Medical Affairs Oncology and stakeholders in Daiichi Sankyo to manage the creation of the product specific Medical Strategy and Objectives

Collaborates with all Medical Affairs functional owners to define and maintain a detailed project plan in alignment with overall Medical Strategy and Objectives

In conjunction with Medical Affairs leadership defines and implements operational and working standards in support of the product, including governance, meeting cadance, decision making procedures and communication

Closely monitors and provides regular reports on the progress of Medical Affairs activities; identifies risks and issues to the overall strategic and tactical plan

Manages budgets and vendor/agency activities as needed and provides regular reporting on budget and financial metrics Aligns Medical Affairs activities with the overall Tumor Strategy and/or Brand Management plan including cross-functional deliverables jointly owned by departments such as Marketing and Market Access

Builds slide decks, dashboards, and Medical Affairs project communications

Assist in advisory board preparations, management of projects with agencies, and key operational initiatives requiring planning and follow up. Defines meeting agendas, facilitates meetings, and issues meeting minutes

Manages budgets and provides regular reports on budget and financial metrics as required

When applicable works with an Alliance counterpart to assure effective collaboration across both organizations

**Qualifications**

**Education Qualifications**

BS Degree required with Master's Degree preferred. A PhD or PharmD with appropriate relevant pharmaceutical experience preferred

**Experience Qualifications**

7 or more years overall related experience or commensurate education/experience required

4 or more years relevant medical affairs experience with strategic experience

**Travel Requirements**

Some travel may be required.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

**Salary Range:**

USD$162,400.00 - USD$243,600.00

[Download Our Benefits Summary PDF](<https://dmscdn.successfactors.com/886bee122c7aa5b9923a39bc71a2674d43c27f80448c122562765b1812b407af/static_content/1659df144cbb4da8ae09/2026_BenefitsHighlightsForPublicPosting.pdf>)

Professionals

Regulatory Submission Manager

**Senior Manager, Regulatory Submission**

**Locations:**  King of Prussia, PA | Glattburgg, Switzerland | Maidenhead, UK

**Work Arrangement:** Hybrid — 3 days onsite

**Reports to:**  Global Submission Management Lead

CSL’s R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a strong focus on collaboration, we’re building a future-ready organization that thrives in dynamic biotech ecosystems. Join CSL and become part of an agile team committed to developing therapies that make a meaningful difference for patients around the world.

**The Opportunity**

Could you be our next Senior Manager, Regulatory Submission?

As a key member of the Global Regulatory Submission Management Team, you will help ensure the timely, high-quality, and compliant delivery of regulatory submissions across global markets. You will work closely with Regulatory, Project Management, Publishing, cross-functional teams, and external partners to coordinate submission activities, manage risks, and ensure adherence to global regulatory and publishing standards.

This is a hands-on leadership role that combines submission management, vendor oversight, regulatory publishing, planning, and process improvement. While much of the publishing activity is managed by external partners, you will provide oversight and may step in directly to publish or coordinate submissions when needed.

**What You’ll Do**

- Oversee external publishing and Global Submission Coordinator activities, ensuring work is delivered according to quality, compliance, and timeline expectations.
- Manage vendor performance, resource allocation, operational standards, and business continuity while contributing to the evolution of the global vendor operating model.
- Identify, assess, and escalate risks that could impact submission timelines or regulatory outcomes.
- Coordinate and prioritize regulatory submissions across portfolios and support submission planning activities.
- Oversee the preparation, publishing, and submission of high-quality regulatory packages, including eCTD, NEES, and paper submissions for investigational, marketing authorization, lifecycle management, and post-approval applications.
- Support submissions for a range of regulatory applications, including NDA, BLA, IND, CTA, PSUR, and Variations.
- Partner with Regulatory Project Managers and cross-functional teams to support submission strategy, planning, and execution.
- Provide submission planning support, including Excel-based roadmaps, storyboards, and briefing book timelines when a dedicated Submission Project Manager is not assigned.
- Ensure regulatory submissions meet technical format requirements, global standards, quality expectations, and applicable timelines.
- Monitor evolving regulatory publishing requirements and contribute to continuous improvement of global submission processes and standards.

**What You’ll Bring**

- Bachelor’s degree or higher in Life Sciences, Pharmacy, or a related field.
- 5+ years of regulatory experience within the pharmaceutical industry, preferably with experience in regulatory publishing or submission management.
- Experience with dossier preparation and regulatory submissions for core and international markets.
- Familiarity with local health authority dossier standards across markets such as the EU, US, Canada, Switzerland, and Australia, as well as applicable ICH guidelines.
- Hands-on experience with electronic document management or regulatory information management systems, such as Veeva RIM.
- Experience working with external vendors, outsourced teams, or service providers; vendor management experience is highly desirable.
- Strong understanding of regulatory submission processes, publishing requirements, quality standards, and submission timelines.
- Strong organizational and communication skills, with the ability to manage multiple priorities and collaborate effectively across functions and geographies.
- Previous people leadership experience is a plus.

**Why Join CSL?**

At CSL, you’ll have the opportunity to work at the intersection of science, innovation, and global regulatory strategy. You’ll play an important role in helping bring innovative therapies to patients while working with talented colleagues and external partners across a global organization.

\#LI-HYBRID

**About CSL Behring**

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit [https://www.csl.com/](<https://www.csl.com/>) and CSL Plasma at [https://www.cslplasma.com/](<https://www.cslplasma.com/>).

**Our Benefits**

For more information on CSL benefits visit [How CSL Supports Your Well-being | CSL](<https://www.cslbenefits.com/csl/candidates>).

**You Belong at CSL**

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

**Equal Opportunity Employer**

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit [https://www.csl.com/accessibility-statement](<https://www.csl.com/accessibility-statement>).

BioMarin Pharmaceutical Inc.

(CW) Contracts Associate (Legal Department) Contract

Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

It takes a village, and at BioMarin, our general and admin teams are the village behind our success. From the IT experts who manage our technology to the human resources professionals who hire the people who make it all possible, these teams support our organization and span all areas of operations.

Hybrid position; Candidate must be in-office in San Rafael on Tuesdays and Thursdays\*\*\*

Contracts Associate-Contract role

BioMarin is seeking a Contracts Associate to join our Legal Department. This role offers an excellent opportunity for an organized, detail-oriented professional to gain hands-on experience supporting enterprise-wide contracting within a dynamic biotechnology company.

The Contracts Associate will work closely with attorneys, Global Sourcing and Procurement (GSP), and business partners across the organization to draft, negotiate, track, and manage a high volume of contracts. Using established templates, playbooks, and procurement and contract management systems, the successful candidate will help facilitate efficient contract execution while ensuring compliance with Legal policies and procedures.

This position is well-suited for candidates interested in pursuing law school/a legal career. Recent college graduates are eligible to apply.

BioMarin offers competitive salaries and benefits with onsite amenities including collaborative indoor and outdoor spaces and an onsite coffee bar and café.

Contract Associate responsibilities include the ability to:

• Research prior contracting relationships with suppliers and other contracting parties.

• Draft and negotiate a variety of company agreements including Non-Disclosure Agreements, Master Service Agreements, Amendments, Scopes of Work, and Change Orders, using BioMarin templates, in BioMarin’s procurement and contract lifecycle management (CLM) systems.

• Utilize Legal Department playbooks and approved guidance to negotiate contracts within established parameters.

• Monitor and track a large volume of contracts from draft to final signatures using the CLM.

• Ensure company-wide compliance with BioMarin's contracting policy and procedures.

• Serve as a liaison among Legal, Global Sourcing and Procurement (GSP), business partners, and external contracting parties to facilitate contract review, negotiation, and execution.

• Build collaborative relationships with internal stakeholders to understand and respond to contracting needs.

• Exercise sound judgment within defined procedures and practices to determine action, including identifying issues and escalating matters to in-house counsel when appropriate.

• Support Legal Department initiatives, including maintaining templates and playbooks, training users on contract management processes, and improving operational efficiencies.

• Provide support for departmental projects and cross-functional initiatives as assigned.

Required Qualifications

• Ability to work onsite at least two days per week (currently Tuesdays and Thursdays), with occasional additional onsite days as needed.

• Must be detail oriented, self-motivated, a quick learner, and have a strong work ethic.

• Strong analytical and problem-solving skills.

• Strong proofreading and editing skills.

• Strong written and verbal communication skills, with the ability to interact professionally and timely with internal and external stakeholders including suppliers/partners, outside counsel, internal legal team, business partners, GSP, and other stakeholders; proactively communicate relevant issues and deadlines.

• Excellent organization and time management skills required; Ability to manage multiple priorities, meet deadlines, work effectively in a fast-paced environment with a heavy workload, and work under pressure.

• Strong technology aptitude and willingness to learn new systems, processes, and enterprise AI tools.

• Proficiency with Microsoft Office applications, including Word, PowerPoint, and Excel.

• Demonstrated initiative, accountability, sound judgment, and a collaborative approach.

Preferred Qualifications

• Experience as a contracts administrator or contracts associate.

• Coursework in legal studies or experience at a law firm or within an in-house legal department of a public company.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Ireland Safety Responsibility

Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

California

AbbVie

Director I, siRNA Discovery Research

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

This role will serve as a key scientific and strategic leader within BGM, shaping AbbVie's siRNA discovery portfolio and enabling the successful translation of RNAi technologies into differentiated therapeutic candidates across multiple Therapeutic Areas.

Lead the advancement and expansion of a cross-therapeutic siRNA portfolio by leveraging and evolving AbbVie's established RNAi capabilities, driving asset strategy, and partnering closely with Therapeutic Areas to identify, prioritize, and advance high-value opportunities. This leader will direct a multidisciplinary team of 10+ scientists and drive scientific, portfolio, and organizational decisions that accelerate the progression of siRNA medicines from concept to development candidates.

Responsibilities:

- **Define and execute the strategic roadmap for siRNA discovery capabilities**, aligning platform investments and portfolio priorities with the needs of AbbVie's core Therapeutic Areas to build a sustainable pipeline of differentiated genetic medicine opportunities.
- **Partner closely with Therapeutic Area leaders to identify, evaluate, and prioritize therapeutic opportunities**, applying rigorous scientific and business criteria to focus resources on programs with the highest probability of success and impact.
- **Lead the advancement of early discovery siRNA programs from concept through candidate-enabling validation**, utilizing milestone-based decision making, clear Go/No-Go criteria, and a fast-fail, fast-learn approach to portfolio progression.
- **Serve as the primary scientific and strategic interface between BGM and Therapeutic Areas**, ensuring alignment on program objectives, timelines, risks, and development strategies while fostering productive cross-functional partnerships.
- **Drive scientific innovation by integrating emerging advances in RNAi technologies**, including oligonucleotide chemistry, delivery systems, and targeting approaches, while establishing external collaborations that strengthen AbbVie's competitive position in the field.
- **Recruit, develop, and lead a high-performing multidisciplinary team**, fostering a culture of scientific excellence, innovation, accountability, and collaboration, while representing BGM discovery efforts across governance and strategic leadership forums.

Qualifications

- Ph.D. in Molecular Biology, Biochemistry, Chemistry, or a related field, or a related discipline, with 10+ years of biotech/pharmaceutical industry experience.
- Deep expertise in siRNA therapeutics, oligonucleotide chemistry, RNA biology, genetic medicines, or related drug discovery modalities.
- Demonstrated track record of leading discovery-stage programs and advancing therapeutic assets through key decision points.
- Experience building and leading multidisciplinary scientific teams, including direct people management and talent development.
- Proven ability to influence and partner effectively across matrix organizations, including Therapeutic Areas, Safety, CMC, and Clinical Development.
- Strong external scientific presence with experience establishing productive collaborations with academic and industry partners.

**Preferred**

- Experience advancing siRNA or ASO programs into development.
- Knowledge of oligonucleotide delivery technologies and emerging RNA-targeting approaches.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Massachusetts

Clinical Research Associate II

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

Purpose :

Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging new advanced capabilities to drive industry leading performance.

Partners with the investigator and site staff for meaningful and effective engagements positioning AbbVie as the choice in clinical trials. Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.

Responsibilities :

- Considered as the primary point of contact for the investigative site. High level of competency or experience in providing contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie’s positioning.
- Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership.
- Conducts site evaluation, site training, routine, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.
- Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.
- Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey.
- Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.
- Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development.
- May participate in global/local task forces and initiatives. Responsible for activities as assigned by manager.
- Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.
- Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.
- Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.
- Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
- Ensures audit and regulatory inspection readiness at assigned clinical site at all times.
- Manages investigator payments as per executed contract obligations, as applicable.

Significant Work Activities:

- Driving a personal auto or company car or truck, or a powered piece of material handling equipment
- Frequent to continuous computer usage (greater or equal to 50% of the workday) is required
- Frequent to continuous computer usage (greater or equal to 50% of the workday) is required

Qualifications

- Bachelor's Degree in health related disciplines (Medical, Scientific, Nursing) preferred.
- Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials. Familiar with risk‐based monitoring approach, onsite and off site monitoring.
- Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
- Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
- Demonstrate strong cross-functional collaboration skills among internal and external stakeholders.
- Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in adynamic environment with competing projects and deadlines.
- Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.
- Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.
- Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issues.
- Acts with integrity in accordance with AbbVie code of business conduct and leadership values. Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.
- *This position requires regular driving and eligibility to operate a company vehicle, subject to the applicable AbbVie policies and procedures.*

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Other Non-US

Clinical Research Physician

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

PURPOSE STATEMENT: Clinical Research Physician represents frontline scientific expertise for assigned AbbVie TA development in China. Provides clinical science insights on portfolio assessment, developmental plan formation, protocol discussion, trial quality and safety oversight, registration approval, and life cycle management. Supports decision of TA Science Lead for achieving the scientific goals with quality evidence and thoughts; establishes scientific partnerships with China academia. Within TA areas, the position works with Global & JAPAC development teams, Clinical Development Operations (CDO), Regulatory Affairs, Medical Affairs, and Commercial Development, to: 1) identify unmet medical needs for related TA development assets, 2) lead China local development project team to propose development strategies and clinical pathways for new compound registration in China, 3) participate protocol discussion from China, 4) ensure study level safety and quality with CDO and investigators during the trial conduct, 5) support regulatory submissions. JOB RESPONSIBILITIES: 1. Supports the TA Head and Global TA Science Lead, proposes development strategies and clinical pathways for new compound registrations in China. 2. Acts as China Local Development Project Lead to assess new trial opportunities. Provides scientific expertise in prioritizing diseases and compounds for China, including opportunities for alliances and partnerships. Provides China scientific inputs to the global TPP. 3. Provides China clinical expertise to design clinical development plans and protocol discussion, ensuring the study design meeting the local regulatory requirements, aiming for efficient development tactics for registration. 4. Initiates proper Development-led medical activities, i.e. medical surveys, Ad Board meetings, KOL visits and other insights development, to support clinical development plan formation and execution. 5. Works closely with Regulatory Affairs to develop efficient pathway for registration with scientific justification, generating and reviewing China regulatory filing materials, based on clinical expertise from CTA through NDA approval. 6. Establishes scientific partnership with Chinese academia and key study centers for effective planning and high-quality implementation in China. 7. Provides medical/scientific training on program specific standards to CDO and investigators to ensure consistency through the process of design, conduct and reporting of clinical trials. 8. Provides local medical support to Global study team, including trial medical monitoring, responding to protocol-specific site questions, resolving data queries, and performing analysis to address questions on efficacy and safety etc. 9. Ensures seamless communication and handover to medical affairs of approved indications and support launch activities. 10. Ensures all activities are in compliance with all applicable national laws and regulations, guidelines, codes of conduct, AbbVie's policies, procedures and accepted standards of best practice. KEY INTERFACES: 1. Affiliate: RA, Commercial Development, CDO, Market Access, Medical Affairs, Public Affairs 2. JAPAC R&D and NPI members 3. Global ADT members 4. Chinese academia 5. Regulatory authority 6. Health authority

Qualifications

IDEAL CANDIDATE: 1. Medical Degree. With a strong medical background of related TA area, some knowledge of the drug development process and the regulatory framework for clinical development. Working experiences (≥ 3 years) in medical and clinical development group of pharmaceutical (or biopharmaceutical) company or equivalent clinical practice is essential. 2. Understanding of the developmental program interplay among Regulatory Affairs, Clinical Development and Commercial objectives. Experienced in leading multiple, diverse clinical development programs is plus. 3. Have insights to study design, good knowledge of data collection, management, analysis, and interpretation are required. 4. Strong verbal and written communication skills are required to complement the ability to analyze and summarize scientific/clinical data and develop recommendations that affect the conduct of trial and the content of regulatory documents. 5. Effective collaboration with peers, stakeholders and partners to achieve positive impact to development results. 6. High customer orientation and patients-centric thinking. 7. Strong commitment to be compliant with all the relevant rules and procedures, and to scientific quality and integrity. 8. Fluent spoken English and solid written English skills.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

Purpose

Describe the primary goals, objectives or functions or outputs of this position.

Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging new advanced capabilities to drive industry leading performance.

Partners with the investigator and site staff for meaningful and effective engagements positioning AbbVie as the choice in clinical trials.

Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.

Responsibilities

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

- Considered as the primary point of contact for the investigative site. High level of competency or experience in providing contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie’s positioning.
- Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership.
- Conducts site evaluation, site training, routine, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.
- Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.
- Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey.
  Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.
- Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development.
  May participate in global/local task forces and initiatives. Responsible for activities as assigned by manager.
- Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.
- Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.
- Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.
- Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
  Ensures audit and regulatory inspection readiness at assigned clinical site at all times.
  Manages investigator payments as per executed contract obligations, as applicable.

Qualifications

Qualifications

List required and preferred qualifications (up to 10). Include education, skills and experience.

- Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred.
- Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials. Familiar with risk‐based monitoring approach, onsite and offsite monitoring.
- Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
- Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
- Demonstrate strong cross-functional collaboration skills among internal and external stakeholders.
- Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
- Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.
- Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.
- Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issues.
- Acts with integrity in accordance with AbbVie code of business conduct and leadership values. Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Immunocore

Senior Director, Regulatory Affairs

Vacancy Name

Senior Director, Regulatory Affairs

Vacancy No

VN870

Employment Type

Full Time

Location of role

Gaithersburg, MD, Radnor, PA, Oxford, UK

Department

Regulatory Affairs

Key Responsibilities

The Senior Director of Regulatory Affairs will be responsible for assigned projects and all of the regulatory affairs activities by providing expertise to Immunocore’s development programs to include regulatory scientific and tactical strategy development, IND development/submission/maintenance, BLA/sBLA development/submission/maintenance, agency liaison and regulatory intelligence. The role will also involve interacting with our global sites, both in-house and outsourced. Establishing a successful relationship with the FDA, along with being responsible for overseeing submissions to the EMA, and MHRA providing a fantastic and unique opportunity to develop worldwide regulatory experience.

The ideal candidate will have experience gained in biologics and the preparation of late-stage regulatory fillings supported by excellent leadership skills. This role will also require someone who can work within a highly innovative, agile and entrepreneurial environment and is able to lead the regulatory strategy through effective collaboration and be able to deliver and work well under pressure as this will be a high-profile role.

This role will be responsible for presentations of proposed scientific and tactical regulatory strategies at Immunocore governance meetings, with an ability to make appropriate changes based on feedback leading to full alignment. This role will also be responsible for providing regulatory leadership for implementation of plans within a project team, including leadership for all health authority interactions globally. As the organization grows this role will be responsible for overseeing, guiding and mentoring direct reports for their assigned projects, either as support for the same assigned project and/or for another assigned project. The role will also provide review/guidance and approval for direct reports and dotted line reports regulatory tactical and administrative plans to ensure consistency across the organization. This role will also provide preliminary review of direct reports regulatory scientific strategies and discuss with Head of Regulatory Sciences to gain alignment prior to governance meeting review(s).

KEY RESPONSIBILITIES

• To provide regulatory leadership and support to cross functional development project teams to jointly achieve strategic objectives.

• To be responsible for the US regulatory activities associated with the project teams.

• Develop regulatory scientific and tactical strategies and target labelling to support development of products.

• Provide leadership for the development and writing of regulatory submission documents, ex. Briefing documents, IND/CTA supporting documents, labelling, and CTD/BLA/MAA documentation for eCTD compliant submissions.

• You will manage, prepare, co-ordinate and be responsible for the submission of the documentation supporting regulatory submissions to the US and wider international regulatory authorities, in support of CTA/INDs, BLAs/MMAs, CTA safety reports and updates, along with all other regulatory submissions.

• To be the center of excellence (point of contact) of all regulatory requirements and guidelines globally, in particular within the US, and monitoring the regulatory environment for oncology, anti-infectives, autoimmune diseases, and biologics.

• Contribute to the establishment and development of procedures and working practices commensurate with the requirements of a company in late-stage development and commercialization.

• Overseeing regulatory review of clinical trial labelling and CMC submissions for regulatory compliance, in junctions with the Director of Regulatory CMC.

• Will need to demonstrate a high level of professionalism, efficiency and leaderships within the team whilst demonstrating critical thinking, effective problem solving and a strong knowledge of regulatory strategies and alignment with all necessary compliance.

• To be responsible for reviewing and ensuring the quality of detailed scientific and technical information are presented clearly and supporting conclusions are adequately evidenced by the data.

• To review and provide input/guidance and approval for tactical and administrative plans for more junior level global regulatory leads and ensure consistency of implementation across the organization. This will be for both direct reports and others with a dotted line reporting for such reviews.

• Provide input/guidance for scientific regulatory strategies for direct reports and discuss with the Head of Regulatory Sciences prior to governance meetings to ensure alignment.

SUPERVISORY RESPONSIBILITY

This position may include line manager responsibilities for direct reports and dotted line reporting

• Leads a review and approval of tactical and administrative regulatory plans to ensure global consistency of both direct reports and dotted line reports for these regulatory aspects.

• Provides guidance to direct reports for scientific regulatory strategies and gains alignment with Head of Regulatory Sciences.

• Promotes communication and cooperation among functions to create a spirit of unity in the organization

EXPERIENCE & KNOWELEDGE

Essential

• Solid track record in drug development and leadership within a dynamic project team(s)

• Solid scientific background with evidence of ability to develop regulatory scientific strategies.

• Strong understanding of global regulatory requirements to be able to form tactical regulatory strategies.

• Excellent knowledge of US regulatory requirements and extensive experience with submissions gained within drug development. Global experience desirable. Experience in working cross functionally and globally within Regulatory Affairs.

• Experience in supporting global clinical studies

• Experience in managing, preparing, submitting INDs/CTAs, BLAs/NDAs, and MAAs. Submission of at least 1 NME BLA/NDA is highly desirable.

• Experience in preparing and conducting Health Authority Meetings (FDA required). Ability to develop and maintain an ongoing liaison relationship with FDA and other global Health Authorities.

• Demonstrate ability to be agile to accommodate changing priorities

• Must have proven leadership, excellent communication and interpersonal skills.

Preferred Experience & knowledge

• Experience in preparing and conducting Health Authority Meetings (FDA required). Ability to develop and maintain an ongoing liaison relationship with FDA and other global Health

Authorities.

EDUCATION & QUALIFICATIONS

Advanced degree preferred – M.S., PharmD, Ph.D., or M.D. with 8-12 years’ experience or BS with 10-15 years’ experience.

US Salary Range

$250,000- $270,000

About the Company

Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry’s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits.

Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.

Maryland

Senior Manager, Medical/Regulatory Writer

Vacancy Name

Senior Manager, Medical/Regulatory Writer

Vacancy No

VN831

Employment Type

Full Time

Location of role

Gaithersburg, MD, Radnor, PA, Remote, US

Department

Regulatory Affairs

Key Responsibilities

The Senior Manager, Medical/Regulatory Writer will be accountable for leading and overseeing the medical and scientific regulatory writing for assigned programs to support submissions from first-in-human studies through product registration. This role involves strategic planning and coordination across multiple functions to ensure consistency and quality in all regulatory documents. The Senior Manager, Medical/Regulatory Writer will report to the Director Medical Writing and will interact with regulatory, PV, preclinical, clinical, translational medicine, PK/PD, and medical affairs groups working across functions to provide writing support and contribute to regulatory messaging strategy in collaboration with cross-functional teams.

This Senior Manager, Medical/Regulatory Writer will not only perform required writing within their scope and abilities but will also coordinate all aspects of medical writing for the assigned programs in the pipeline in collaboration with each functional group to ensure consistency of messaging. The Senior Manager, Medical/Regulatory Writer will assist and provide necessary support to the teams in the creation of effective internal and external communications and documents for submission to health authorities. This Senior Manager, Medical/Regulatory Writer will coordinate the activities of all external (contract) writers contributing to each project.

The ideal candidate will have a scientific background or degree, excellent leadership skills, have experience gained from working in the pharmaceutical industry (preferably with biologics), experience in the preparation of the necessary and essential documents to support regulatory fillings from first-in-human through marketing applications. This role will also require someone who can work within a highly innovative, agile, and entrepreneurial environment. The candidate will be able to provide input into the messaging strategy through effective collaboration and be able to deliver and work well under pressure to achieve timelines and ensure compliance with regulatory requirements.

KEY RESPONSIBILITIES

• Writing responsibilities across preclinical, clinical development, medical affairs, translational medicine, and regulatory affairs.

• Authoring clinical study protocols in collaboration with the clinical scientist/clinical project manager and study medical monitor

• Authoring or supervising the preparation of other regulatory documents required for Health Authority submissions, including but not limited to: Clinical Summaries (Clinical Overview, ISS/ISE, PK/PD summary, Advisory Committee Briefing document), Investigator Brochure(s), DSURs, other regulatory documents including briefing documents for health authorities, responses to Health Authority questions, etc.

• Authoring clinical study reports (CSR) from individual clinical studies.

• Complying with internal and external processes and guidelines while managing the writing review process and resolving issues, errors, or inconsistencies with pertinent team members to ensure timely completion and quality of assigned documents.

• Managing and coordinating all external writers supporting assigned programs to ensure consistency of messaging and timely delivery of documents per project plans.

• Provide input for the development and writing of regulatory submission documents, ex. Briefing documents, IND/CTA supporting documents, labelling, and CTD/BLA/MAA documentation for eCTD compliant submissions.

• Contribute to the establishment and development of medical writing procedures and best practices.

• Responsible for maintaining archival files of regulatory documents that must have a controlled limited-access version maintained in a secure area.

• As assigned, perform quality control (QC) review of documents which are part of various regulatory submissions as per project requirements. Examples include to look for typographical, grammatical/spelling, formatting, flow and language and general clarity of text.

SUPERVISORY RESPONSIBILITY

This position has no direct supervisory responsibilities of Immunocore personnel but will oversee and coordinate the activities of external (contract) writers,

Experience & knowledge

Essential

• Track record in writing medical research documents, including protocols, clinical study reports, health authority briefing documents.

• Competent in use of MS Word, macros and templates to enable efficient writing, and the ability to efficiently use Adobe Acrobat to create bookmarked and hyperlinked submission-ready documents.

• Understanding of global regulatory requirements to be able to provide input into writing strategy and messaging.

• Experience in supporting global clinical studies and development programs as a writer.

• Ability to be agile to accommodate changing priorities

• Proven leadership, excellent communication and interpersonal skills.

• Exceptional attention to detail and highly organized.

• Interpersonal skills allowing for interactions with all participants in the writing of documents.

• Capable of maintaining logical processes for the inventory and tracking of documents within the eDMS/RIMS.

Preferred Experience & knowledge

• Experience with use of master and sub protocols, umbrella trials, and/or basket studies.

• Experience with short turnaround RFI responses to health authorities.

• Experience in use of at least one eDMS and/or RIMs system.

• Experience in use of at least one review and collaboration system for reviews of documents.

Education & qualifications

BS with 4-7 years’ experience in medical/regulatory writing and 7-10 years’ industry experience. Advanced degree M.S., PharmD, Ph.D., or M.D. with 3-5 years’ experience.

US Salary Range

$158,000-$185,000

About the Company

Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry’s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits.

Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.