Regulatory

Immunocore

Director, Regulatory Affairs-Global Regulatory Lead

Vacancy Name

Director, Regulatory Affairs-Global Regulatory Lead

Vacancy No

VN723

Employment Type

Full Time

Location of role

Gaithersburg, MD, Radnor, PA, Oxford, UK, Remote, US

Department

Regulatory Affairs

Key Responsibilities

The 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, MHRA, and other local Health Authorities providing an excellent opportunity to develop worldwide regulatory experience.

The ideal candidate will have experience gained in biologics and the preparation of late-stage regulatory fillings, with regulatory tactical leadership skills and implementation. 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.

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 and ex-US regulatory activities associated with the project teams.

• Develop regulatory scientific, and tactical strategic plans, and target labelling to support product development of products.

• Provide leadership for the development and writing of regulatory submission documents, including 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, antifectives, autoimmune diesases, 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 conjunction 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 compliant with all regulations and guidance.

• 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.

SUPERVISORY RESPONSIBILITY

This position does not initially have direct reports but may in the future.

COMPETENCIES

1. Communication Proficiency.

2. Time Management.

3. Collaboration Skills.

4. Personal Effectiveness/Credibility.

5. Flexibility.

6. Technical Capacity.

7. Stress Management/Composure.

IMMUNOCORE VALUES

• We lead with science to benefit patients

• We are entrepreneurial

• We value diversity to drive innovation

• We respect each other and act with integrity

• We do the right thing

PERSON SPECIFICATION

EXPERIENCE & KNOWELEDGE

Essential

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

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

• Strong understanding of global regulatory requirements to be able to form functional 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 for, 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 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.

EDUCATION & QUALIFICATIONS

Advanced degree preferred – M.S., PharmD, Ph.D., or M.D. with 5-10 years’ experience or BS with 8-12 years’ experience.

POSITION TYPE & EXPECTED HOURS OF WORK / TRAVEL

This is a Full Time, Exempt position:

Occasional overtime may be required based on work priorities, outside of general office hours. Limited overnight travel is expected for this position. There may be occasional local day travel.

US Salary Range

$189,500- $235,000

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

Clinical Compliance/Inspection Readiness, Manager - Clinical Operations

Vacancy Name

Clinical Compliance/Inspection Readiness, Manager - Clinical Operations

Vacancy No

VN514

Employment Type

Full Time

Location of role

Gaithersburg, MD, Radnor, PA

Department

Clinical Operations

Key Responsibilities

This is an onsite position and can be located at either our Gaithersburg, MD or Conshohocken, PA sites.

The Clinical Compliance/Inspection Readiness, Manager is responsible for the management and execution of activities associated with inspection preparedness, inspection support, clinical procedural development and maintenance, clinical training programs, and assessment and investigation of clinical quality compliance issues. This onsite position can be located at either our Gaithersburg, MD or Conshohocken, PA sites.

KEY RESPONSIBILITIES

• Lead the development and delivery of GCP and Inspection Readiness training for the Clinical o organization

• Lead the development and implementation of processes and tools to support teams and functions in being inspection ready

• Provide ongoing inspection readiness support and expertise to study teams, including risk mitigation and monitoring

• Execute plans with clinical teams and cross-functionally to prepare for audits and regulatory agency inspections, including support of ongoing storyboarding

• Provide representation for the Clinical Compliance function in Sponsor audits and Regulatory Agency inspections, and supervise Clinical preparation room activities

• Coordinate follow-up within the Clinical organization on all audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA)

• Generate, analyze and communicate inspection readiness metrics

• Drive continuous improvement into inspection readiness and inspection conduct support

• Lead the development and approval of controlled documents related to clinical study processes and systems including Policies, SOPs, Work Instructions, forms and templates in compliance with global regulatory standards

• Lead the strategy execution for role-based curriculum and GCP training within the Clinical organization

• Collaborate with QA with the preparation/collection of all training documents in preparation for internal training file audit (e.g., completed SOP matrices, CVs, JDs etc.)

• Assist with oversight and/or conduct compliance assessments including but not limited to vendor/contractor qualification assessments in collaboration with Quality Assurance

• Assist with management and oversight of the tracking of Suspected Serious Clinical Non-Compliance Issues (SSCNCI), including reporting (if applicable) and ensure follow-up and

closure

• Support the completion of internal audit reports and collaborate with the Quality function(s) to assess process improvement and/or training needs and opportunities.

• Manage follow-up within the Clinical organization on all audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA)

• Track status of open Quality Issues and CAPAs and coordinate with Clinical stakeholders to ensure timely and adequate closure, as appropriate

• Generate, report, and respond accordingly to compliance/inspection readiness KPIs

OTHER DUTIES

• Support and prepare internal and external clinical operations teams for audits

• Provide training on Clinical Standard Operating Procedures and Work Instructions to ensure compliance with regulatory organizations.

• Support and manage in collaboration with Quality Assurance the clinical quality database observations

• Identify opportunities and provide leadership in continuous improvement of good clinical practices.

• Establish and assure adherence to budgets, schedules, work plans, and performance requirements, relative to inspection readiness support and clinical compliance activities.

• Regularly communicate with senior management or executive levels on matters regarding several functional areas

Experience & knowledge

Essential

• At least 8 years relevant experience in a biotechnology/pharmaceutical industry and/or contract research organization (CRO) with experience in compliance, quality, training or related clinical operations function.

• Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EUCTD, and ICH GCP.

• Ensure an enthusiastic and open attitude towards continuous professional development

• Experience with the following skill set:

o Performing PAI and Inspection readiness assessments

o Making high level presentations, both orally and in writing using organizational skills to

complement this

o Delivering open and honest constructive (positive and/or negative) feedback pertaining to

work in hand

oTaking responsibility and ownership for entrusted tasks; seeing tasks through to completion

and dealing with the consequences of failure or success.

o Being flexible to new ideas and approaches; changes of plans, objectives and/or priorities.

Handling disjointed tasks effectively. in a highly collaborative, multi-disciplinary team setting.

o Being able to work productively with others to achieve tasks while showing consideration

for the needs and feelings of others.

o Accomplishing goals under project timelines.

Desirable

Prior experience with the following would be an advantage

• Clinical auditing and relevant clinical operations functions

• Compliance and training

Education & qualifications

• BA / BS. or higher in science related field (biological science, medical, pharmacy or other health related discipline)

• 8+ years’ experience in related area with some experience in QA/Audit setting preferred

• Clinical Operations and/or Inspection Readiness experience preferred

• Demonstrated computer skills; proven functional knowledge of Microsoft packages (MS Word, Excel, Power Point, Outlook, MS Project, SharePoint)

Some international and local travel maybe required. Approximately up to 20 % travel.

$107,250-$178,750

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.

United States Pharmacopeia

Senior Enterprise Policy Development Manager

**Description**

**Who is USP?**

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world’s leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide.

At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health.

USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds—regardless of background—to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.

**Brief Job Overview**

The Senior Enterprise Policy Development Manager develops and manages a portfolio of evidence-based policy content that supports Global External Affairs (GEA) priorities and advances USP's mission to improve the supply of quality medicines and health products. This role is responsible for developing enterprise policy materials, including public policy statements, white papers, journal articles, presentations, and formal comments to government agencies and other external stakeholders. Working collaboratively across USP, the position convenes internal and external stakeholders, leverages scientific and public health expertise, and builds partnerships to inform policy content and support research collaborations. The role partners closely with colleagues across functions, geographies, and stakeholder groups to ensure enterprise policy initiatives and deliverables align with GEA objectives and USP's strategic priorities, while delivering high-quality work within established timelines.

**How will YOU create impact here at USP?**

As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards.

Additionally, USP’s People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments.

**The Senior Enterprise Policy Development Manager has the following responsibilities:**

- Partner with USP scientific, public health, and external affairs colleagues to develop credible, evidence-based enterprise policy content and support informed dialogue on issues relevant to USP's mission.
- Convene and engage internal and external stakeholders to gather perspectives, build alignment, and inform the development of policy content and program priorities.
- Cultivate and support collaborations with academic institutions, consultants, and other external partners to advance policy priorities and support evidence-based policy development.
- Manage and execute a portfolio of enterprise policy content in support of GEA priorities, including public policy statements, white papers, journal articles, presentations, and formal comments to government agencies and other stakeholders.
- Develop and implement programs, forums, and communication approaches that increase awareness and utilization of USP's policy content among key stakeholder audiences.
- Partner across the enterprise to ensure policy initiatives, content, and stakeholder engagement activities are aligned with GEA priorities and USP's strategic plan.
- Execute to deadlines on enterprise policy program goals: Expect 3-4 major projects to be completed per year.

**Who is USP Looking For?**

The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:

- Bachelor’s degree in relevant field.
- Very strong writing skills. Demonstrable experience in writing and managing the development of substantive policy materials in a variety of forms and for different audiences ( *g* ., policymakers, regulatory leaders, stakeholder organizations, *etc.*  ).
- Willingness and ability to learn new information rapidly.
- Demonstrable ability to work collaboratively across functions to build consensus and execute to deadlines in a fast-paced environment.
- Some familiarity with drug development and regulation.

**Additional Desired Preferences**

Desired preferences include highlighting any additional preferred levels of expertise for the role—reminder: items listed here are not requirements and do not disqualify a candidate from consideration.

- Advanced degree in public policy, public health, law, science, medicine, or other related field.
- Progressively responsible experience in life sciences, public health, public policy, regulatory affairs, government, non-profit, or related sectors, including experience managing complex projects and working across multiple stakeholder groups.
- Experience in biological product research and/or development.
- Broad or specific familiarity with key issues affecting drug and food product quality, including (for example) international regulatory frameworks, trade policy, supply chain management, the application of artificial intelligence to quality frameworks, environmental sustainability, or advanced manufacturing technologies.
- Experience with public speaking on complex topics.
- Experience working with international stakeholders.

**Supervisory Responsibilities**

None, this is an individual contributor role.

**Benefits**

USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.

**Compensation**

Base Salary Range: USD $127,100.00 – $152,332.00 annually.

Target Annual Bonus: % Varies based on level of role.

Individual compensation packages are based on various factors unique to each candidate’s skill set, experience, qualifications, equity, and other job-related reasons.

**_Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP._**

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.

**Job Category** Ext. Affairs, Regulatory, & Communications

**Job Type** Full-Time

Scientist IV, Analytical Research & Development

**Description**

At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health.

USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds—regardless of background—to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.

**Brief Job Overview**

This is a non-supervisory position to support process development and scale-up of Active Pharmaceutical Ingredient (API) and related materials. The successful applicant in this role will work on projects including Analytical Method Development and evaluation for in-process samples for synthetic chemistry. The successful candidate will also perform a variety of non-routine and routine analytical tests, maintains safety & GLP environment in the lab including development/validation of methods, stability studies and research projects in analytical chemistry. The successful applicant will direct, troubleshoot, and share insights on complex projects while drawing independent conclusions about the results and determining how to proceed with the project. They closely collaborate with other scientists and/or other USP personnel.

**How will YOU create impact here at USP?**

As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards.

Additionally, USP’s People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments.

The Scientist IV has the following responsibilities:

- Support reaction monitoring, scale-up and final analysis of samples as per monograph /in-house procedures including method development/validation if required. Prepare development reports for Synthetic Support projects. Execute projects per the approved test protocols if assigned.
- Plan, execute, and complete the projects as per specifications, timelines, and budget.
- Responsible for preparation and review of SOPs, protocols, reports, etc.
- Ensure project requirements by coordinating with external vendors and all internal relevant departments.
- Responsible for ensuring the required maintenance and calibrations of the equipment
- Responsible for preparing, executing and completing IQ/OQ/PQ of new instruments as assigned
- Preparation and planning for ISO-9001 certification/recertification by participating actively, verification of protocols and related documents and take an active role in the internal as well as external QA audits and address the audit issues in a timely manner.
- Maintain GLP & implement safety procedures while working in Lab.
- Work on any other assigned tasks/ lab management activities.
- Conversant with lab safety norms and strictly follow them.
- Collaborate within the team and cross functional teams
- Learn and practice Diversity, Equity, Inclusion & Belonging culture

**Who is USP Looking For?**

The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:

The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:

- Sc. in Analytical Chemistry / Organic Chemistry/M. Pharm, having 8-10 years of experience in Analytical Research and Development or Ph.D. with 4-7 years of experience in Analytical Research and Development.
- Must have hands on experience in working with chemical methods and handling instruments like HPLC, GC, LC-MS, GC-MS, FTIR, UV-Visible, wet chemistry, etc.
- Experience in analytical testing and development with focus on process analytical chemistry and to understand, monitor and control chemical processes/reactions.
- A comprehensive understanding of the science involved in the development of synthetic organic molecules and analytical chemistry.
- Ability to perform analytical method developments and method validations as and when required.
- Excellent technical writing and verbal communication skills
- Good interpersonal skills and proven ability to function in a team-oriented environment are necessary.

We especially welcome applications from those who hold historically marginalized and/or underrepresented identities. This job description provides a portrait of an ideal candidate. Candidates who possess many, though perhaps not all, qualifications are encouraged to apply.

**Additional Desired Preferences**

Desired preferences are to showcase any additional preferred levels of expertise to perform the role. Reminder: any items listed in this section are not requirements nor disqualifies for candidate consideration.

- Understanding of process analytical technology, chemometrics, and knowledge of in-line, online, at line process analytical tools (e.g., IR, Raman, HPLC)
- Evaluation of process monitoring, understanding, and control via in line, online and at line techniques. Serve as technical expert and champion for PAT and/or process model building.
- Experience with a wide variety of software and laboratory information systems, including chemometric modeling software
- Working knowledge of API manufacturing and product testing (e.g. ICH guidelines, USP general chapters and monographs)
- Expertise with USP compendial methods and requirements (e.g. monographs and general chapter) and ICH quality guidelines
- Pharmaceutical laboratory experience, method development and method implementation in manufacturing environments, and/or continuous manufacturing experience.
- Strong project management skills with ability to be effective both independently and in collaborative teams
- Skilled in evaluation and interpretation of data; Ability to multi-task.
- Skilled in anticipating, troubleshooting, and solving technical problems.
- Takes personal responsibility to ensure work is delivered on time and is of the highest quality.

**Supervisory Responsibilities**

NA

**Benefits**

USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.

**Only listed for USA job opportunities**

Base Salary Range: USD $\[XX,XXX – XX,XXXX\] annually.

Target Annual Bonus: % Varies based on level of role.

Individual compensation packages are based on various factors unique to each candidate’s skill set, experience, qualifications, equity, and other job-related reasons.

Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.

**Job Category** Chemistry & Scientific Standards

**Job Type** Full-Time

Other Non-US

Senior International Regulatory Affairs Manager

**Description**

**Who is USP?**

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world’s leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide.

At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health.

USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds—regardless of background—to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.

**Brief Job Overview**

The Senior International Regulatory Affairs Manager serves as a critical enabler of regulatory engagement and influence to support the realization of USP’s mission priorities in regions across the globe. The Senior Manager will lead the development of a portfolio of evidence-based regulatory content than could include analyses, toolkits and other materials to support engagement with regulators aligned with enterprise priorities. The role collaborates across USP functions and regions to translate scientific and regulatory information into practical policy resources that strengthen engagement with regulatory authorities worldwide and supports the understanding and application of USP standards and programs. This role will also develop and lead a platform to connect and engage regulators across the regions on topics relevant to USP’s mission. The role reports to the VP, International Government & Regulatory Affairs (IGRA) and is a key role within the broader Global External Affairs function.

**How will YOU create impact here at USP?**

As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards.

Additionally, USP’s People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments.

**The Senior International Regulatory Affairs Manager has the following responsibilities:**

- Lead the development of a portfolio of evidence-based regulatory content that could include analyses, toolkits and other materials that support enterprise priorities and that can be deployed to and tailored in regions. The Sr. Manager will engage with global commercial teams and Global External Affairs colleagues to assess opportunities and needs to inform the focus of the content and then lead its development in collaboration with cross-functional USP teams. Potential topical areas include API quality; standards for biologics; new biologic / peptide treatments; appropriate use of quality standards; integration of digital tools into quality assurance.
- Support the deployment of the developed content across regions and stakeholder groups, including developing a process by which feedback from USP colleagues and stakeholders can guide content updates and future priorities.
- Lead planning, implementation, and ongoing management of a global USP Regulators Forum designed to facilitate dialogue among regulatory authorities on pharmaceutical quality topics, support knowledge exchange, and strengthen engagement with USP standards and scientific leadership.
- Provide targeted country-level support as assigned.

**Who is USP Looking For?**

The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:

- Bachelor’s degree required in relevant field (Life Sciences, Public Policy, Public Health, Political Science, Law, Pharmacy, Medicine, etc.).
- Eight (8) years of experience working in regulatory intelligence, regulatory affairs, public policy, or public health that includes experience working with international teams.
- Prior experience working for a science-based organization related to public health or life sciences. (e.g., NGOs, government, non-profit organization, or industry/private sector organizations.)
- Experience with and knowledge of regulatory policy making processes and analysis, including researching writing policy briefs, policy positions and other tools.
- Experience developing evidence-based policy positions, including demonstrated ability to translate scientific or regulatory information into clear, accurate and understandable content tailored to a variety of audiences.
- Excellent communication, presentation, and interpersonal skills, as well as experience communicating across cultures.
- Strong analytical and writing skills, with the ability to synthesize and report complex information, and to develop applicable strategies to align with expected outcomes.
- Project management and organizational skills, as well as ability to adapt to internal and external changes.

**Additional Desired Preferences**

- Advanced degree (Life Sciences, Public Policy, Public Health, Political Science, Law, Pharmacy, Medicine, etc.) or other related field preferred.
- Experience working in a matrixed organization.
- Expertise in conducting literature searches and evidence-based reviews, soliciting expert opinion through various methods, and writing/editing sound scientific reports on a wide variety of topics and issues related to public health and public policy.
- Ability to influence and drive cross-functional initiatives without direct authority.
- Familiarity with pharmaceutical quality standards and their application in regulatory or laboratory settings.

**Supervisory Responsibilities**

None, this is an individual contributor role.

**Benefits**

USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.

**Compensation**

Base Salary Range: USD $126,250.00 – $171,578.00 annually.

Target Annual Bonus: % Varies based on level of role.

Individual compensation packages are based on various factors unique to each candidate’s skill set, experience, qualifications, equity, and other job-related reasons.

**_Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP._**

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.

**Job Category** Ext. Affairs, Regulatory, & Communications

**Job Type** Full-Time

Pharmaceutical Compounding & Standards Intern | Dr. Loyd Allen USP Experiential Internship

**Description**

**Application Deadline:**  October 9, 2026

Background

Dr. Loyd V. Allen, Jr., was a preeminent leader in the field of compounding pharmacy in the USA and beyond. His contributions left an indelible mark on the pharmacy profession in many ways, such as authorship of various seminal academic works and mentorship of students and pharmacist colleagues. He also served as an expert volunteer for USP and in numerous capacities for several decades, starting in the early 1990s. The Education Grant will target an early career pharmacist or other healthcare professional interested in gaining knowledge and experience in pharmaceutical compounding at USP. The Education Grant is supported by ARL BioPharma, and additional contributors are welcome to provide additional support via ARL (contact: Dr. Tom Kupiec at tkupiec@arlok.com). USP independently manages the selection and work of the selected candidate.

Key Responsibilities

The selected candidate will spend a period at USP and work on projects on a variety of topics, including the following areas:

1. **Compounding and USP Standards:**

- Development of a deep understanding of USP compounding standards and stakeholder engagement
- Research on current trends and developments in pharmaceutical compounding such as innovations in facility design, quality assurance and quality control, compounding of investigational substances, handling hazardous drugs, and emerging technologies.

1. **Development of Implementation Tools for USP compounding standards,**  including external communications, educational course development, and digital resources.
2. **Laboratory Studies and Monograph Development,**  includingevaluation and analysis of method validation and stability reports
3. **Supporting Compounding Expert Committee activities,**  including contributing to planning and organizing activities of expert committees on special compounding topics.

Qualifications and Eligibility

- Advanced degree in pharmacy or pharmaceutical sciences (e.g., Ph.D., PharmD)
- Must not be concurrently employed. Pharmacy residents and fellows are eligible but will need to provide USP with written permission from their programs to participate in this education grant opportunity.
- Strong interest in compounding, regulatory affairs, and standards development.
- Ability to conduct research (literature, web, USP internal data) and write about their research (e.g., peer-reviewed journal articles).
- Excellent writing, communication, and presentation skills.
- Ability to work collaboratively in a multidisciplinary environment.

Duration

The Education Grant position will be awarded once every year on an annual rolling basis. The education grant will be on a part-time basis to last up to 6 weeks and will be non-renewable. The exact duration will be determined by the project designed and approved by the Education Grant administrators.

Stipend

The recipient of the Grant will receive a one-time stipend of $5,000. The Stipend will be used to support personal logistics (e.g. travel and temporary housing), registration and attendance at relevant conferences, and other grant-related costs.

Location

The fellow will be hosted by and carry out their primary activities at the USP headquarters in Rockville, MD, with hybrid/remote options, as appropriate.

**Application Deadline:**  October 9, 2026

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.

**Job Category** Contingent Staff

**Job Type** Part-Time

Senior Director, Global Programs (Regulatory and Laboratory)

**Description**

**Who is USP?**

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world’s leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide.

At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health.

USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds—regardless of background—to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.

\*\*Brief Job Overview \*\*

This role, a critical member of the Global Health and Manufacturing Services (GHMS) leadership team, is responsible for developing and implementing a global growth strategy for USP’s externally funded regulatory and laboratory programs. The incumbent will be primarily responsible for developing long-term strategic relationships with potential funders and partners which drive towards shaping and ultimate realization of new opportunities for programming in the United States and internationally. Additionally, she/he, will represent USP externally as a thought leader in a variety of forums and will supervise a global team across Africa and Asia.

**How will YOU create impact here at USP?**

As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards.

Additionally, USP’s People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments.

\*\*The Senior Director, Global Programs (Regulatory and Laboratory) has the following responsibilities: \*\*

- Develop and continuously adjust USP’s growth strategy for regulatory and laboratory programming.
- Interface and partner with external and internal stakeholders, including potential funders, to understand evolving regulatory and laboratory technology landscape and customer needs.
- Align existing USP offerings and solutions to meet customer needs and develop new offerings in the regulatory and laboratory space to address gaps.
- Represent USP externally as a thought leader in technical discussions and in external forums to advance programming growth.
- Provide technical support and input to relevant funding proposals; and lead the develop of proposals with a primary focus on growing the regulatory and laboratory program.
- Manage and deploy global team to support growth strategy and implementation of secured programming.
- Support and / or oversee implementation of funded programming including providing strategic and technical oversight for specialized health systems programming, with a strong focus on regulatory strategies, strengthening National Regulatory Authorities (NRAs), pharmacovigilance (PV), post-market surveillance systems, and clinical study capacity for Bioequivalence/Bioavailability (BE/BA) trials.
- Be a thought partner to other leaders within the GHMS team as we collectively advance USP’s mission and broader strategic goals.
- Other duties as assigned.

**Who is USP Looking For?**

The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:

- Bachelor's or advanced degree in scientific, regulatory or related field.
- Minimum of five (5) years’ experience in regulatory role within or interfacing with stringent regulatory authority/authorities.
- Minimum of ten (10) years’ experience in Good Practice guidelines and regulations in pharmaceuticals and/or biologics (GxPs).
- Experience with/ understanding of WHO regulatory processes.
- Minimum of five (5) years in roles with international scope.
- Minimum of seven (7) to nine (9) years of people management experience.
- Proven track record of thought leadership as evidenced by speaking engagements/ panel roles and/ or publications/ other content generation.
- Willingness/ ability to travel at least 25% domestically and internationally.

**Additional Desired Preferences**

- Demonstrated ability to design, manage, and implement complex projects.
- Active network with potential funding sources / entities, including global (such as Gates, Global Fund) and domestic funders (such as Department of War, Health and Human Services, etc.).
- Experience and/or exposure with the changing landscape of regulatory and laboratory science as applied to new manufacturing and quality modalities (e.g., advanced manufacturing, AI-enabled processes, non-destructive testing).
- Relevant work experience in a lower middle income country (LMIC).
- Experience working in program / project management or other relevant technical area in DARPA, BARDA, JPEO-CBRAND or similar.

**Supervisory Responsibilities**

Yes, the following direct reports:

- Director / Sr Manager, International regulatory and laboratory programs
- Senior Pharmacovigilance Manager
- Senior Technical Advisor

**Benefits**

USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.

**Compensation**

Base Salary Range: USD $208,060.00 – $262,150.00 annually.

Target Annual Bonus: % Varies based on level of role.

Individual compensation packages are based on various factors unique to each candidate’s skill set, experience, qualifications, equity, and other job-related reasons.

Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.

**Job Category** Ext. Affairs, Regulatory, & Communications

**Job Type** Full-Time

LATAM Government and Regulatory Affairs Manager - Mexico

**Description**

**Who is USP?**

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world’s leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide.

At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health.

USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds—regardless of background—to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.

**Brief Job Overview**

The LATAM Government and Regulatory Affairs Manager – Mexico will share USP’s vision of better-quality health for everyone and will contribute to advancing USP’s public health mission and long-term sustainability in the region. The role will support the execution of government affairs, regulatory affairs, and stakeholder engagement initiatives across Mexico and the LATAM Region, in close collaboration with the LATAM Government and Regulatory Affairs Director and the USP Global External Affairs Division.

This position will help build and maintain strategic relationships with government authorities, regulatory agencies, industry associations, and other key stakeholders to support scientific, regulatory policy, and collaborative initiatives that advance the quality supply of medicines, food ingredients, and dietary supplements.

In addition, the role will coordinate and support initiatives aimed at strengthening USP’s visibility and relevance in Mexico and supporting the sustainable operation of USP in the country. The position will serve as USP’s local representative in Mexico and will report directly to the LATAM Government and Regulatory Affairs Director based in Brazil.

**Location** : Mexico City, Mexico.

**How will YOU create impact here at USP?**

As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards.

Additionally, USP’s People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments.

The LATAM Government and Regulatory Affairs Manager – Mexico has the following responsibilities:

**Regulatory Affairs**

- Support and manage relationships with regulatory and government stakeholders in Mexico and across the LATAM Region, partnering with USP internal resources to advance science- and policy-based collaboration opportunities.
- Support advocacy initiatives related to regulatory policy and quality standards.
- Monitor, analyze, and communicate regulatory developments related to medicines, dietary supplements, and other applied programs relevant to USP.
- Provide insights and recommendations regarding regulatory trends and potential impacts on USP programs and regional strategies.
- Collaborate with internal stakeholders to support the development and execution of appropriate responses and engagement plans.

**Public Policy / Government Affairs**

- Monitor and assess public policy developments impacting medicine quality, patient safety, and healthcare access.
- Support engagement with decision-makers and participation in relevant forums, associations, and discussions to advocate for quality and public health priorities.
- Build and maintain collaborative relationships with public-sector stakeholders and identify partnership opportunities aligned with USP’s mission.
- Support stakeholder mapping, prioritization, and execution of engagement plans in collaboration with USP colleagues and subject matter experts.

**Other Stakeholder Engagement**

- Support engagement with key stakeholders in the region, including professional organizations, trade associations, academic institutions, and patient groups.
- Build and maintain productive relationships that support USP’s visibility, reputation, and mission in the region.

**USP International Government and Regulatory Affairs Team**

- Contribute as a member of the USP International Government and Regulatory Affairs team by providing regional insights, supporting global initiatives, and sharing best practices with colleagues across geographies.

**Mexico Country Coordination**

- Serve as USP’s local representative in Mexico, supporting country-level coordination efforts and cross-functional initiatives.
- Coordinate with internal USP teams involved in strategic initiatives aimed at strengthening USP’s positioning and engagement within the Mexican healthcare sector.
- Support initiatives that promote USP’s visibility and relevance in Mexico, including collaboration with key stakeholders and participation in U.S.-Mexico binational initiatives when appropriate.

**Who is USP Looking For?**

The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:

- Bachelor’s degree in public health, science, political science, law, or another relevant field.
- At least six years of progressively responsible experience working in regulatory affairs, government affairs, public policy, or related functions in Mexico and/or the LATAM Region.
- Experience building and maintaining relationships with key stakeholders in healthcare, regulatory, or government environments.
- Demonstrated experience working with or engaging government policy and/or regulatory bodies on scientific and regulatory policy topics.
- Experience working within matrixed and multicultural organizations.
- Strong communication and stakeholder management skills.
- Professional proficiency in Spanish and English.
- Availability to travel across the LATAM Region (approximately 30%–40%).

**Additional Desired Preferences**

- Advanced degree in public health, science, politics, law, or another relevant field.
- Knowledge of the regulatory environment and healthcare policy landscape in Mexico and LATAM.
- Knowledge of the life sciences industry, especially in areas related to regulatory affairs, public policy, and product quality.
- Strong analytical and policy assessment skills.
- Ability to work collaboratively across functions and influence stakeholders without direct authority.
- Self-motivated, proactive, and capable of managing multiple priorities effectively.
- Strong relationship-building and collaboration skills.
- Solution-oriented mindset with the ability to identify practical and effective approaches to complex issues.

**Supervisory Responsibilities**

None, this is an individual contributor role.

**Benefits**

USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.

Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.

**Job Category** Ext. Affairs, Regulatory, & Communications

**Job Type** Full-Time

AbbVie

Senior Clinical Research Associate

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

- For assigned sites/study(s), ensure successful protocol level execution of SMM deliverables involving start-up, execution, and close-out. Ensure site related study execution including but not limited to monitoring visits, site evaluations, site selection, and activation, and monitoring close out and visit reports. Anticipate and identify site issues that could affect timelines and develop alternative solutions.
- Ensure clinical trial management systems containing all site-specific information are maintained and kept current. Provide Local regulatory and legal requirement expertise. Ensures timely payment execution for the assigned sites/study(s) according to the clinical study agreements and as per local requirements.
- Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. Stay abreast of new and/or evolving local regulations, guidelines and policies.
- Ensure audit and inspection readiness of assigned sites. Advise on pre-audit activities for GCP requirements. Prepare and follow up site audits/inspections; provide input into the CAPA preparation.
- Responsible for coaching and mentoring CRAs and providing input into their development. Responsible for mentoring CRAs for various aspects of work.
- May be responsible for being the country point of contact for CROs for an assigned study. May participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by manager.
- If assigned; Responsible for identifying training needs and standardizing and facilitating training solutions for SMM monitors globally. Provide consistent best practice approach to onboarding, consolidating “lessons learned” across areas and incorporating into monitoring training materials, defining best practice training curriculum, and maintaining awareness of upcoming changes to ensure effective training is delivered in a timely manner.
- If assigned; With guidance, may serve as key point of contact in country/district for assigned study. Update Impact/Tesla with country-level information: Country-level planning timelines, LSR assignments, etc.
- If assigned; Global Representative for a single or multiple studies, collaborating with key stakeholders to achieve proactive, strategic and tactical success throughout the study planning, execution, and closeout phases leading to World Class clinical trials.
- If assigned; Responsible for remote data review of assigned sites/studies according to the Integrated Data Review Plan (IDRP), Monitoring Plan, SOP/WI and in accordance with the study timelines and objectives. Provides feedback on investigators/sites on an on-going basis based on the site performance. Interacts and builds professional and collaborative relationships with peers and site monitors.

Qualifications

- Education: Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred.
- Site Monitoring Experience: Minimum 3 years.
- Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making.
- Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity. Demonstrated proactive and positive team player.
- Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment with competing projects and deadlines.
- Demonstrated business ethics and integrity.

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>)

Regulatory Affairs Supervisor

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

**PRIMARY FUNCTION/OBJECTIVE**

The position is to handle preparation of regulatory submissions in order to obtain and maintain marketing approvals of company products, and to provide advice on regulatory matters to staff and customers.

**CORE JOB RESPONSIBILITIES**

- Manage registration of new products and variations to marketed products to ensure regulatory approvals are achieved in accordance with company objectives.
- Ensure new product registrations and approval maintenance is conducted in a timely manner according to the registration plan, with guidance from RA manager where required.
- Coordinate responses to deficiency letters and other requests for data from regulatory authorities for products and ensure it meets agreed or required timelines.
- Liaise with officials of government agencies to facilitate evaluation processes and respond to requests for data in agreed timelines.
- Update product labeling in a timely manner based on the update of the product labeling from headquarters.
- Review labeling and product information to ensure compliance with relevant regulations and codes.
- Generate registration plans and provide regular status reports.Report progress and status to manager and management as required including to corporate RA and NPI meetings.
- Communicate regulatory issues and evaluate the impact on the business to RA director, senior management and Business Unit, and to GM where applicable, under the supervision of RA manager.
- Maintain good knowledge of relevant corporate policies and local regulations and ensure compliance.
- Keep abreast of regulatory changes and evaluate the impacts on the business and communicate changes in a timely manner to related parties and management.
- Update RA SOPs when regulations and processes are updated and review them to ensure they are within the validity timeframe.
- Participate in RA process and streamline processes to increase productivity.
- Other regulatory projects and tasks assigned by RA Director/Senior Manager/Manager/Associate Manager.

Qualifications

- University degree in Pharmacy, Pharmacology, Biology or related disciplines
- Minimum 3 years’ experience and in-depth knowledge of Taiwan Regulatory in new drug applications for NCE
- Good communications and coordination skills
- Strategic and analytical thinking
- Proficiency in communicating strategic and tactical issues
- Proven interpersonal 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>)

Insmed Incorporated

Senior Director, Regulatory Affairs CMC

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

We’re looking for a Senior Director, Regulatory Affairs CMC to help us expand what’s possible for patients with serious diseases. Reporting to the VP, Regulatory Affairs CMC, the Senior Director will provide regulatory CMC (RA CMC) leadership and strategy to achieve regulatory approvals in various countries.

As a strategic function, RA CMC is required to collaborate closely with multiple functions within Insmed and with external CROs/CMOs. A successful candidate will provide knowledge, understanding, interpretation, and utilization of regulatory guidance and regulations from various health authorities, as well as industry and government agency best practices and trends.

**What You'll Do:**

In this role, you’ll have the opportunity to plan, execute, and manage regulatory submissions for compounds in various phases of clinical development, marketing applications, and post-approval lifecycle activities by working with various teams. You’ll also:

- Provide regulatory strategies and identify the gaps and challenges of CMC development to ensure the approvability of the drug products worldwide with the flexibility for post-approval maintenance and lifecycle management of the marketed products.
- Perform due diligence assessment of potential drug products of small and large molecules.
- Develop plans for the preparation of CMC meetings with the regulatory agencies, and draft and review regulatory documents for CMC meetings with the agencies.
- Provide interpretation of applicable FDA/EMA/ICH/WHO global regulations to ensure CMC compliance within regulatory filings.
- Keep abreast of all pertinent regulations and guidance documents for pre- and post-approval submissions.
- Communicate regulatory CMC requirements to team members and advise of implications of the regulatory CMC strategies to CMC development plan and activities.
- Contribute to scientific discussions and collaborations with scientists to resolve technical and regulatory issues in drug substance synthesis, management of impurities and degradation products, formulation, manufacturing process, and device combination product development at various development stages and product lifecycles.

**Who You Are:**

You **must** have a Bachelor’s degree and 10+ years of pharmaceutical development and regulatory CMC experience supporting both small- and large-molecule products within multinational companies, including experience serving as a Regulatory Affairs CMC product lead. Additionally, you have:

- Experience in the drug substance and drug product development of small and large molecules in terms of manufacturing process development and impurity controls.
- A solid understanding of US, EU, and Japanese regulations for drugs/biologics with the ability to identify the differences in regulations across the regions.
- Proven ability to liaise with Regulatory Agencies in agency interactions and product development meetings.
- Knowledge of scientific principles and regulatory CMC requirements relevant to global drug development and post-market lifecycle support.
- Working knowledge of relevant FDA, EU, ICH, PMDA guidelines, initiatives and regulations governing CMC drug product development.
- Ability to deal with issues of critical importance, provide regulatory strategy/advice and make reasoned decisions on CMC regulatory issues for which they may not be clear or with specific regulatory guidance.
- Proven success with end-to-end project management within RA CMC or relevant experience.

- Strong communication skills with the ability to effectively present ideas and influence others to achieve desired results. Ability to read and collate scientific and medical literature.
- Ability to lead others to move internal and external teams towards achieving goals that support Insmed’s key strategic objectives.
- Experience operating as a flexible and diplomatic individual; able to effectively deal with ambiguity, problem solve, and work effectively across functions as a team player.

**Nice to Have (but not required):**

- Advanced degree (MS, PhD, or PharmD) strongly preferred.

**Where You’ll Work**

This is a fully remote role. It can be performed effectively from anywhere while staying connected to yourInsmedteam and community.Occasional travel for team meetings or eventswillbe expected.

**Travel Requirements**

This position involves occasional domestic and/or international travel (approximately 10%).

\#LI-Remote

\#LI-MM

**Pay Range:**

$222,000.00-303,000.00 Annual

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All 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. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Nationwide

Senior Manager, Regulatory Affairs Process Excellence

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

The **Senior Manager, Process Excellence within Regulatory Affairs**, is responsible for managing key process excellence and issue management activities that support compliant, efficient, and inspection-ready Regulatory Affairs operations. This role oversees the Regulatory Affairs Issue and CAPA Management system (RAIM), triages issue records, escalates issues to Exception Reports when warranted, and partners cross-functionally to drive process improvements. Through collaboration with functional and cross-functional stakeholders, the position also supports inspection readiness and audit/inspection response activities, and management of change plans for legacy company integrations into Regulatory Affairs business processes.

**Responsibilities:**

- Manage the Regulatory Affairs Issue and CAPA Management system (RAIM) to ensure issues are appropriately logged, assessed, tracked, and resolved
- Triage RAIM issue records to determine severity, impact, and appropriate next steps
- Escalate issue records to Exception Reports when needed based on risk, compliance impact, or process significance
- Project manage Exception Reports in partnership with cross-functional stakeholders to identify root causes, drive corrective actions, and improve AbbVie processes
- Collaborate with Regulatory Affairs leaders, Business Process Owners, Quality, and other functions to ensure issue management activities are timely, well-coordinated, and effective
- May provide support during internal and external audits and inspections, including coordination of documentation, issue follow-up, and response support as needed
- Manage multiple legacy company integrations for Regulatory Affairs business processes through change plans in OneTrack
- Ensure process documentation, issue records, and change plans are maintained accurately and in alignment with applicable governance expectations
- Partner with stakeholders to support effective communication, implementation, and adoption of process changes.
- This role will work a hybrid work schedule (3 days in office, 2 days remotely) from our Lake County, IL AbbVie headquarters.

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

- Required Education: Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology or related subject). Preferred Education: Relevant advanced degree in science or business is preferred. Certification a plus
- Required Experience: 8+ years of regulatory, pharmaceutical or device experience.
- Experience in Regulatory Affairs, Quality, process excellence, business process management, or related roles is preferred
- Experience managing issue/CAPA systems, exception reporting, or comparable compliance and investigation workflows
- Experience supporting audit and inspection readiness in a regulated environment
- Strong organizational, analytical, communication, facilitation, and stakeholder management skills
- Ability to manage multiple priorities and work effectively across functions and levels
- Ability to influence without direct authority and work in a matrixed environment

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>)

Illinois

Associate Director, Regulatory Affairs Advertising & Promotion - Oncology

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

The **Associate Director, Regulatory Affairs US Advertising and Promotion-Oncology** is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes multidivisional initiatives. The Associate Director envisions the future by using global marketplace, technology and business knowledge, collects and analyzes issues and trends that affect the business. This individual identifies and acts upon cross-organization or cross-business opportunities and possesses and leverages broad industry knowledge.

**Responsibilities:**

- Make decisions and plans for operations (workflow, assignments, staff development) within area of responsibility with minimal direction. Sets strategy and leads cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives.
- Maintains and evaluates productivity metrics to project current and future business needs
- Aligns and maintains effective communication channels with key Medical, Marketing, Regulatory, Legal and Public Affairs counterparts. Identifies areas of improvement in process/policy, develops recommendations/plan, and leads initiatives.
- Assists in the management of the departmental budget, identifies and communicates budgetary needs to Operations and Finance, and identifies and projects current and future expenditures and business needs.
- Collects and analyzes issues/trends that affect business to identify and act on cross-organization or cross business opportunities. Effective use of knowledge of global marketplace, technology and business levels.
- Operates independently, with recognition of when to consult departmental senior concerning risks. In absence of Director, is responsible for day-to-day operations. Responsible for departmental initiatives, which have significant impact on both internal and external customers.
- Encourages innovation and holds employees accountable for delivering on their goals; recognizes, mentors, rewards and recommends promotion for staff members based on their performance, results, and development.
- Exhibits solid understanding of regulations, and guidance of regulatory authorities, political and legal climate and industry practices related to advertising and promotions to assist in meeting organizational goals. Possesses and leverages broad industry knowledge
- Develops and implements complex processes and projects and develops and delivers strategic presentations for senior management
- Identifies areas of improvement in process, policy, develops recommendations/plan and leads initiatives
- This role will work a hybrid work schedule (3 days in office, 2 days remotely) from our Mettawa, IL; South San Francisco, CA; Florham Park, NJ or Irvine, CA AbbVie headquarters

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

- Minimum bachelor’s degree (or equivalent) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), is required. Master’s, Ph.D or Pharm D preferred.
- You should also possess:
  - **Associate Director: 8+ years of pharmaceutical experience with a Bachelor's, 5+ years with a Pharm D plus relevant ad promo experience. Oncology experience is preferred.**
- The candidate must have a solid understanding of regulatory advertising and promotion regulations, having had direct responsibility in this area.
- Experience working in a complex and matrix environment
- Strong communication skills, both oral and written
- Experience in management capacity preferred

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>)

California

Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada

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

The **Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada** is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. The Senior Manager assures that regulatory strategies defined within the GRPT, are effectively implemented and maintained in line with changing regulatory and business needs.This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements.

**Responsibilities:**

- Responsible for a product(s) or products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the development & execution of the regulatory strategy. Assigned matters may have a moderate impact on business activities and operations.
- Serves as HA liaison and interfaces with FDA for meetings, teleconferences and coordinates preparation and completion of FDA meeting briefing packages and responses. Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.
- Functions independently in negotiation and decision-making for project related issues that have crossfunctional impact. Assists in the development,training of staff members.
- Key contributor responsible for the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review.
- Supports the regulatory submission and approval process. Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
- Recommends and implements changes to difficult projects based on knowledge and expertise, accurate interpretation of US and Canada government regulations, guidances, as well as corporate policies and management-related considerations.
- Presents pertinent regulatory information to appropriate cross-functional areas.
- Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).
- This role will work a hybrid work schedule (3 days in office, 2 days remotely) from our Lake County, IL; Florham Park, NJ or Irvine, CA AbbVie headquarters.

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

- Required Education: Bachelor’s degree (pharmacy, biology, chemistry, pharmacology) or industry related.
- Preferred Education: Advanced Degree a plus. Certifications a plus
- Required Experience: Minimum of 6 years of experience in regulatory affairs, research and development, or a related pharmaceutical industry field, including at least 2–3 years of experience performing pharmaceutical regulatory activities.
- Demonstrates excellent negotiation skills, problem solving skills and builds consensus.
- Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization.
- Able to deliver challenging messages effectively without compromising important business relationships.
- Proven skill at implementing successful US and Canada regulatory strategies regulatory strategies.
- Experience working in a complex and matrix environment.
- Global regulatory experience is a plus.
- Experience interfacing with government regulatory agencies.

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>)

Intellia Therapeutics

Director Risk and Compliance Operations

**Why Join Intellia?**

Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.

We wantall ofour people to go beyond what is possible. We aren’t constrained by typical end rails, and we aren’t out to just “treat” people. We’re all in this for something more. We’re driven to cure and motivated for change. Just imagine the possibilities of what we can do together.

**Job Summary**

As we continue our exciting evolution, our Legal team is looking for a strategic leader to help further build and refine our global compliance program as we prepare for commercialization. Reporting to the VP Risk and Compliance, the Director Risk and Compliance Operations **(within Legal)** will lead the operations of Intellia’s Enterprise Risk & Compliance Programs ensuring that systems, processes, and reporting obligations are effectively implemented and maintained. The position emphasizes execution, operational excellence, and project management across monitoring, transparency reporting, training, policy administration, and investigations to help ensure compliance with applicable laws, regulations, and company policies. This is an exciting opportunity for a passionate builder, someone who thrives in fast-paced, high-growth environments and is energized by the challenge of shaping a program. The ideal candidate is ready to roll up their sleeves, partner cross-functionally, and grow.

**Duties/Responsibilities**

- The Director, Risk and Compliance - Operations is an experienced compliance operations leader who combines strategic thinking with strong execution

- Compliance lead for systems, process governance, and reporting enablement, with responsibility for shaping scalable operational solutions that support effective Risk and Compliance programs, including advancing risk and compliance systems roadmaps and overseeing enhancements and release readiness, and ensuring process are scalable, sustainable and aligned with business and regulatory expectations.

- Lead complex cross-functional initiatives, improving data quality and process performance, and addressing operational and regulatory challenges with thoughtful, practical solutions.

- Oversee and scale internal investigations process, including program process for case intake, evidence collection, case tracking and tracking of remediation activities and support ongoing monitoring of corrective actions.

- Support the corporate ERM and audit programs aligned to the compliance risk assessment.

- Own compliance tooling strategy and operations (case management, approvals workflow, third-party due diligence tools, transparency systems, LMS interfaces as needed, analytics).

- Lead vendor governance and performance management for outsourced compliance services.

- Data Strategy and Reporting Enablement: Provide leadership for data governance across compliance-owned systems and datasets by establishing quality standards, definitions, documentation, and control expectations

- This role enables more effective reporting and analytics by improving data completeness, accuracy, and usability and by partnering with stakeholders to define business requirements for dashboards, extracts, and other reporting outputs

- Play a leadership role in building and maintaining a third-party risk management program for compliance risk, including risk-based intake, due diligence, governance, onboarding, renewal, and termination processes

- This role partners across functions to embed appropriate compliance controls into internal and vendor lifecycle activities and helps ensure that operational design keeps pace with evolving business needs and regulatory expectations

- Work across functions and levels of the organization to influence decisions, align priorities, and move initiatives forward

- This person is collaborative, adaptable, and trusted to handle sensitive matters while driving high-impact operational improvements across the compliance program

- Performs other related duties as assigned.

**Requirements**

**Skills/Abilities**

- Ability to build and maintain professional relationships with internal stakeholders

- Demonstrated experience within Legal to lead highly complex initiatives with significant risk and complexity, leveraging strong cross-functional relationships and influencing skills

- Ability to manage multiple priorities in a fast-paced environment with flexibility, commitment to teamwork, and willingness to adapt assignments to meet the Company’s needs

- Ability to partner cross-functionally with IT, Finance, Legal, and business stakeholders to drive adoption and timely delivery of system/process enhancements, including communicating with senior/executive leaders as a functional area expert

- Strong project/program management experience, including managing scope, timelines, risk/issues, and cross functional stakeholders

- Strong analytical and problem-solving skills with strong attention to detail and accuracy; ability to translate complex data/process topics into clear insights and recommendations

- Strong presentation and communication skills (written and verbal), including creation of executive-ready materials and facilitation of working sessions

- Manages sensitive and confidential matters with discretion and sound judgment

- Proficiency with Microsoft Office (Word, Excel, PowerPoint) and familiarity with analytics and work management tools (e.g., Power BI, Smartsheet, Microsoft Project)

- Demonstrated knowledge of regulatory/compliance requirements applicable to corporate compliance (e.g., Anti-Kickback Statute, False Claims Act, Foreign Corrupt Practice Act, and state price transparency laws and regulations), experience with healthcare compliance programs a plus.

- Demonstrated ability to design and govern compliance systems and system-enabled processes, including defining controls, translating requirements into system/process configurations, and ensuring sustainable operating procedures

- Strong understanding of data governance concepts and ability to establish data quality standards, definitions, and reporting requirements to support reliable analytics and decision-making

- Learning agility: ability to quickly learn new subject areas and support emerging priorities as directed

- Produces high-quality work with minimal oversight from manager

**Education / Certifications**

- Bachelor’s Degree in business, finance, life sciences, healthcare, information systems or related field with 12+ years of relevant experience in the life sciences industry (pharmaceutical, medical device or biotech) or,

- Master's Degree/JD with 10+ years of relevant experience in the life sciences industry (pharmaceutical, medical device or biotech)

**Experience**

- 10+ years of experience leading compliance systems and process governance, requirements definition, testing/UAT, implementation and continuous improvement and making decisions and recommendations regarding organizational practices, policies and systems. OneTrust and Diligent experience are a plus.

- 10+ years of experience with data governance and operational reporting/analytics (e.g., dashboards, KPIs, data quality)

**Physical Requirements**

Prolonged periods of sitting

**Meet Your Future Team** (N/A unless hiring)

Intellia’s Enterprise Risk & Compliance team is a diverse group of superheroes tasked with protecting the organization through enterprise risk management and managing legal, operational, and regulatory threats across the organization.

\#LI-KO1

**_EEOC Statement:_**  *Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.*

Applications are accepted on a rolling basis, and will continue to be accepted until the position is filled at which point the position will be taken down.

The base salary for this position is expected to range between $214,137.00 - $261,723.00 USD per year.

The salary offered is determined based on a range of factors including, but not limited to, relevant education and training, overall related experience, specialized, rare or in-demand skill sets, internal comparators and other business needs. Upon joining Intellia, your salary will be reviewed periodically and additional factors such as time in role and performance will be considered. Intellia may change the published salary range based on company and market factors.

Additional compensation includes a performance-based annual cash bonus, a new hire equity grant, and eligibility to be considered for annual equity awards the value of which are determined annually at the Company’s discretion.

For more information about Intellia’s benefits, please [click here](<https://www.intelliatx.com/careers/join-us/>).

Massachusetts

Sr. Intellectual Property (“IP”) Counsel

**Why Join Intellia?**

Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.

We wantall ofour people to go beyond what is possible. We aren’t constrained by typical end rails, and we aren’t out to just “treat” people. We’re all in this for something more. We’re driven to cure and motivated for change. Just imagine the possibilities of what we can do together.

The Sr. IP Counsel plays a critical role in overseeing and managing certain aspects of the company's legal matters, specifically intellectual property. This position is responsible for providing legal advice on patents, trade secrets, copyrights, and trademarks; developing and executing a global intellectual property strategy in support of Intellia’s gene editing technology and pipeline programs; ensuring compliance with company policies; and managing intellectual property portfolios and proceedings. The ideal candidate has a strong background in patent prosecution, optionally with additional experience in patent litigation, broad knowledge of intellectual property law, effective at communicating at all levels of the organization, the ability to work effectively in a fast-paced environment and wants to be fully integrated into every aspect of the company from research to business execution.

**Duties/Responsibilities**

**The key responsibilities that are specific to the position include:**

- **Global IP Strategy & Portfolio Development**:
  - Lead the development and management of a worldwide IP portfolio, with a focus on CRISPR-Cas9 genome engineering, therapeutic applications, and Intellia’s gene editing pipeline.
  - Identify patentable inventions through close collaboration with R&D teams; draft, file, and prosecute patent applications globally via internal and external counsel.
- **Legal Advisory & Risk Management**:
  - Provide strategic legal advice to scientific, business, and legal teams on IP matters, including patents, trade secrets, trademarks, and copyrights.
  - Conduct due diligence (landscape, FTO, infringement, validity analyses) and develop risk assessments/mitigation strategies for research, partnerships, and transactions.
- **Transactions & Business Support**:
  - Advise on and negotiate agreements supporting business goals, including licensing, collaborations, consulting, research, vendor, and manufacturing contracts.
- **Patent Litigation & Dispute Resolution**:
  - Collaborate with Intellia’s litigation attorneys to manage and defend Intellia’s IP in proceedings such as PTAB challenges, oppositions, and other global forums.
- **Stakeholder Engagement & Collaboration**:
  - Interface with internal teams, external collaborators, government agencies, and third parties to align IP strategy with business objectives.
  - Collaborate cross-functionally to integrate IP considerations into R&D, commercialization, and operational decisions.
- **Training & Oversight**:
  - Provide IP training and education to employees to foster awareness and compliance.
  - Manage outside counsel to ensure cost-effective, high-quality legal representation.
- **Additional Duties**:
  - Support other legal matters and projects as needed to advance company priorities.

**Supervisory Responsibilities**

**If a people manager:**

· Recruits, interviews, hires, and trains new staff.

· Oversees the daily workflow of the department.

· Provides constructive and timely performance evaluations.

· Handles discipline and termination of employees in accordance with company policy.

**Requirements**

**Skills/Abilities**

**Technical Expertise**:

- Proven track record in patent preparation, prosecution, and analysis (U.S. and international).
- Experience with IP due diligence, freedom-to-operate (FTO), infringement/validity assessments, and risk mitigation.
- Proficiency in patent searching tools and Microsoft Office Suite.

**Core Competencies**:

- **Strategic Leadership**: Ability to set IP strategy, influence business decisions, and manage complex legal/business risks.
- **Collaboration & Communication**:
  - Excellent verbal/written communication and presentation skills; ability to simplify complex IP concepts for diverse audiences.
  - Strong client-service focus with experience working cross-functionally (R&D, business development, legal).
- **Execution & Agility**:
  - Thrives in a fast-paced environment; manages multiple priorities and deadlines with flexibility.
  - Strong analytical, problem-solving, and legal drafting skills; creativity in developing pragmatic solutions.
- **Leadership & Mentorship**:
  - Demonstrated ability to lead teams, mentor junior staff, and manage outside counsel effectively.
  - Supervisory experience with a focus on fostering collaboration and accountability.

**Preferred Attributes**:

- Experience in PTAB proceedings, oppositions, or other IP litigation.
- Familiarity with CRISPR-Cas9, gene editing, or therapeutic development.

**Education / Certifications**

- **Required**:
  - Juris Doctor (J.D.) or LL.M. from an accredited law school.
  - Admission to practice law in at least one U.S. jurisdiction.
  - Registered to practice before the U.S. Patent and Trademark Office (USPTO).
  - 8–10+ years of experience practicing patent or intellectual property law, specifically in life sciences, biotechnology, or pharmaceuticals, with a focus on preparation, prosecution, and IP analysis.
- **Strongly Preferred**:
  - Advanced scientific degree (Ph.D. or Master’s) in molecular biology, cell biology, biochemistry, chemistry, immunology, genetics, structural biology, or a related field.
  - Equivalent scientific/engineering experience (e.g., industry R&D roles) may substitute for an advanced degree.

**Experience**

· Minimum of 8+ years of experience in intellectual property law, including significant prior legal experience in the pharmaceutical and/or biotechnology fields, with an emphasis on preparation, prosecution, and/or IP strategy and analysis.

· Experience in all aspects of U.S. and foreign intellectual property law relating to biotechnology, pharmaceutical, or life sciences at a law firm or a biotechnology/pharmaceutical corporation.

· Demonstrated leadership, management, and interpersonal skills, and creativity in applying analytical frameworks and solutions to issues.

· Experience negotiating, drafting, and interpreting license agreements preferred but not required.

**Physical Requirements**

· Prolonged periods of sitting at a desk and working on a computer

· Ability to be onsite in Cambridge periodically.

· Ability to travel periodically for legal proceedings or other projects, as needed.

\#LI-KO1

**_EEOC Statement:_**  *Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.*

Applications are accepted on a rolling basis, and will continue to be accepted until the position is filled at which point the position will be taken down.

The base salary for this position is expected to range between $268,728.00 - $328,446.00 USD per year.

The salary offered is determined based on a range of factors including, but not limited to, relevant education and training, overall related experience, specialized, rare or in-demand skill sets, internal comparators and other business needs. Upon joining Intellia, your salary will be reviewed periodically and additional factors such as time in role and performance will be considered. Intellia may change the published salary range based on company and market factors.

Additional compensation includes a performance-based annual cash bonus, a new hire equity grant, and eligibility to be considered for annual equity awards the value of which are determined annually at the Company’s discretion.

For more information about Intellia’s benefits, please [click here](<https://www.intelliatx.com/careers/join-us/>).

InVitro Cell Research, LLC

Associate Research Scientist, Stem Cells

InVitro Cell Research (ICR) is dedicated to solving some of the most challenging problems in aging and age-related disease. We're hiring **Associate Research Scientists** to join our dynamic, team-oriented environment engage in cutting-edge, high-impact biomedical research.

**With ICR, you'll get to:**

- Research and develop cell-derived interventions for aging and age-related disease
- Explore iPSC-derived extracellular vesicles and organoids for regenerative medicine potential
- Collaborate with other ICR scientists in cutting-edge preventive and regenerative medicine research projects

**Please apply if you have:**

- A BS or MS in a biomedical field
- A solid grasp of modern molecular and cell biology
- At least one year mammalian cell culture experience (required), preferably with iPSCs or other stem cells
- Experience with extracellular vesicles, qPCR and cell-based assays

**And you'll need:**

- An easygoing, friendly personality
- The ability to work in the United States without sponsorship

**Salary**

**Starting** **base pay range:**  $70,000/yr - $90,000/yr

**Starting additional compensation range:**  $5,000/yr - $12,000/yr

Starting compensation is commensurate with experience.

New Jersey

GRAIL Inc

Senior / Staff Data Integrity Engineer (Compliance) #4942

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/>)

As a Senior / Staff Data Integrity Engineer you ensure that GRAIL data within scope of the Data Integrity Policy meets the ALCOA+ attributes. As part of the Data Integrity Office you function as Subject Matter Expert (SME) on Data Integrity topics throughout the data life cycle. You prepare and help with the correct implementation of Data Integrity Requirements, apply Data Integrity principles, perform risk assessments and provide SME support for the correct identification of Data Integrity Impact and Data Integrity Risks within QMS processes. This is a cross functional role that assures regulatory compliance, product quality and patient safety related to data integrity that ensures data integrity and that detects, investigates and corrects where needed.

**Responsibilities:**

- Support the implementation and execution of the GRAIL Data Integrity Program
- Act as Data Integrity Subject Matter Expert within the organization
  - Perform quarterly Data Integrity reviews and generate quarterly reporting
  - Identify Data Integrity risk and/or impact within following processes: CAPA, Non-conformances, Clinical Quality Events, Clinical Protocol Deviations and Change Control Activities
  - Represent Data Integrity interests for supplier, internal and 3rd party Audits
- Able to build alignment with business partners within GRAIL including Clinical Development, Clinical Lab, Software/IT, Research, Manufacturing, Warehouse, Facilities, and Commercial Operations leaders
- Ability to demonstrate strategic thinking capability with a strong project management focus while balancing conflicting priorities
- Enhance relationships and networks with senior partners who are not familiar with the subject matter often requiring persuasion
- Adapt style to different audiences and advise others on difficult matters

**Required Qualifications:**

- The right candidate for this position has a strong background in either GxP Computer system validation or a technical background (IT, SW Development,Clinical Data Management, Data Sciences....) with proven hands on work experience in a GxP environment and data integrity in a GxP context..
- BS/BA degree & 5+ years of related experience or Masters & 3+ years of related experience (pref Life Science, Engineering or Computer/Tech degree)
- Experience includes:
  - Data integrity/ALCOA+/Data Sciences experience in a human pharmaceutical or medical device company
  - Good understanding of Risk and Impact assessments
  - Experience working in a GxP environment
  - Computer System Validation experience, including sound knowledge of 21 CFR Part 11
- 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)
  - Risk assessment frameworks (e.g. ISO 14971)
  - Clinical laboratory regulations (e.g. CAP, CLIA, NYSDOH, ISO 15189)
  - Protected health information (e.g. HIPAA, GDPR)
  - Regulatory submission of medical devices (e.g. IVDD, IVDR, FDA 21 CFR, UK MDR 2002)
  - Development and Operations within a regulated clinical study environment (e.g. ICH E6 (GCP), ISO 20916, FDA 21 CFR Part 11, Part 50, Part 54, Part 56)

**Preferred Qualifications:**

- Excellent communications skills
- Strong Documentation Skills
- You are analytical, can set priorities, have a sense of planning and can work independently
- Quality minded

The expected, full-time, annual base pay scale for this position is $135k-$180k.

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.

Senior Counsel, Enterprise Functions

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 Senior Counsel will become a key partner to support our growing legal needs within AbbVie’s Enterprise Procurement Legal function. The Senior Counsel will join a team of experienced attorneys and paralegals and will provide valuable legal support to various teams within AbbVie’s Business and Procurement functions, including Business Technology Services (BTS), HR/Employee Benefits, Professional Services and Consulting, and Meetings and Events. In this role, the Senior Counsel will be expected to interact regularly and effectively with internal and external business stakeholders. They must be creative, strategic, and innovative while handling a high volume of matters and be focused on bringing those matters to a timely conclusion.

**Primary Job Function:**

- Responsible for preparing, reviewing, and negotiating complex commercial agreements and providing counsel to the various teams within Procurement and relevant Business functions, including Master Services Agreements, consulting agreements, software licensing, cloud and SaaS agreements, technology services agreements, data licensing agreements, AI vendor agreements, HR/benefit agreements, and agreements governing meetings/events.
- Responsible for managing and providing legal support and counsel on a variety of business transactions and supplier issues, including management of dispute resolution.
- Responsible for effectively managing paralegal, external counsel, and contract attorney activity.

**Core Job Responsibilities:**

Responsible for compliance with applicable Corporate Policies and procedures.

The Senior Counsel independently:

- Takes ownership of matters and projects.
- Identifies legal issues for assigned matters and resolves those matters in a timely and practical manner.
- Assists other attorneys and stakeholders in resolving legal issues on cross-functional projects.
- Develops knowledge of AbbVie’s business and client concerns.
- Keeps abreast of changes in the law.
- Represents AbbVie externally to customers, suppliers, and competitors.
- Resolves legal issues using negotiation skills and legal expertise.
- Helps select and direct work of outside counsel.
- Manages and mentors less experienced attorneys and paralegals.

Qualifications

**Minimum Qualifications:**

- Candidates must possess JD degree and state bar certification.
- Minimum 5+ years of experience (8+ years preferred) in corporate or general transactional law or litigation with a pharmaceutical and/or healthcare background, and with a record of demonstrated success in negotiating complex commercial agreements and counseling clients on a wide range of commercial business issues.
- An understanding of legal issues related to data privacy, cybersecurity, artificial intelligence, and intellectual property are beneficial.
- The successful candidate will have strong legal, analytical, problem-solving, decision-making, innovation, risk assessment, drafting, negotiating, and client communication skills.

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>)

Director, RA Global Regulatory Strategy

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

The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy (Neuroscience), is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and throughout the life cycle of the product. Demonstrates excellent understanding of drug development and leadership behaviors consistent with level. Develops and implements acceleration strategies. Manages projects and necessary documentation of reg strategies.

Responsibilities

- Interfaces with the LRST and AST to lead and support cross-functional company objectives. Leads the GRPT to development of creative global strategies in line with applicable regulations to achieve business objectives for development and marketed products. When necessary, seeks expert advice and technical support from functional stakeholders, supervisor, and TAH level personnel.
- Leads cross-functional stakeholders and regulatory professionals to ensure inclusion of appropriate and clear strategic messaging in the content of global regulatory dossiers and responses to regulatory Agency requests.
- Accountable for ensuring that corporate goals are met. Key internal leader and driver of regulatory policy and strategy for assigned products.
- Leads preparation of global regulatory product strategies for assigned products. Proactively leads regulatory and cross-functional team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products and communicates plan to relevant stakeholders.
- Acts independently under the direction of a GRS Sr GRL or TA Head. May participate in or lead regulatory and Company initiatives. Based on experience and scientific strengths, expands knowledge of TA and provides coaching and mentoring for GRPT members. May have direct report(s) and contribute to the performance management for other RA team members
- Influences the development of regulations and guidance. Analyzes legislation, regulations, and guidance and provides analysis to the organization, with worldwide accountability for assigned products.
- Follows company policies and procedures for regulatory record keeping and may identify need for and develop and implement policies and procedures within the RA department and, if applicable, ensure direct reports follow requirements.
- Ensures alignment of global regulatory strategies with Sr. Management. Under minimal guidance of supervisor, presents meaningful regulatory assessments and regulatory recommendations to executive management. Proactively informs AST and cross functional management, including RDLT and Commercial Leadership,of issues, labeling outcomes, approval or other risks and mitigations. Provides assessment of impact on global programs. Represents ABBV Regulatory position in interactions at Joint Governance
- Makes decisions regarding work processes or operational plans and schedules to achieve the program objectives established by senior management. Advances the organization’s goals by participating in and taking leadership roles in professional associations, industry, and trade groups as appropriate for assigned projects.
- Follows budget allocations and keeps supervisor informed on project resourcing (headcount-related fees, filing fees, and professional services).
  Chairs or sponsor key GRS initiatives and presents outcomes to RA LT.

Qualifications

- Required Education:
  Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject.
- Preferred Education:
  Relevant advanced degree is preferred. Certification a plus.
- Required Experience:
  7+ years regulatory experience. Some portion may include experience related to pharmaceutical regulatory work (e.g., other R&D role or specialized training). Requires drug development experience in US&C region. Proven 5+ years in a strategic leadership role with strong project management skills. Experience working in a complex and matrix environment with multiple stakeholders and influencing cross-functional teams. Experience interfacing with major government regulatory
- Required Experience cont'd:
  Strong communication and proactive negotiation skills. Experience developing and implementing successful global regulatory strategies.
- Preferred Experience:
  10+ years’ experience in pharmaceutical regulatory activities, with experience as lead regulatory product strategist in two or more major regions in addition to the US, such as EU or Japan. Strong global drug development foundation with business acumen.
- Note: Higher education may compensate for years of experience.

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>)