Regulatory

Regeneron Pharmaceuticals, Inc.

Executive Director, Responsible AI & Enterprise Governance

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We're looking for an Executive Director, Responsible AI & Enterprise Governance to join our fast-moving Enterprise Data & AI organization. You'll build and run our enterprise AI governance framework, setting the policies, standards, and controls that let Regeneron move fast with confidence, auditability, and trust. You'll partner closely with Legal, Compliance, and the CISO to keep AI use safe, compliant, and aligned with our values. This role reports to the SVP, Chief AI Officer, and offers the chance to shape governance as an accelerant for AI adoption, not a barrier to it.

**When & where:**

- **Location:**  This role is open to any of our Tri-State locations: Sleepy Hollow, NY, Tarrytown, NY, Armonk, NY, Warren, NJ or Cambridge, MA

**Discover your role:**

- Drive the enterprise AI governance program with senior business stakeholders across all Regeneron functions - AI governance forums, use case intake, and enterprise wide accountability
- Lead the citizen development governance program - safe, auditable, enterprise-approved boundaries for non-technical builders
- Define and own Regeneron's enterprise AI governance strategy across all model types, risk tiers, and deployment contexts
- Build and lead a team of specialists across model validation, guardrails engineering, regulatory compliance, and citizen development governance
- Establish the enterprise AI risk framework - taxonomy, classification standards, and control requirements across classical ML, foundation models, LLMs, fine-tuned models, and agentic systems
- Set the technical assurance that includes validation frameworks, red-teaming, production monitoring, and pre-production sign-off gates
- Own the end-end AI model lifecycle governance standard from ideation to deployment and monitoring
- Drive LLM and agentic AI governance - grounding standards, retrieval integrity, tool use controls, autonomous action limits, and human-in-the-loop enforcement
- Own GxP AI validation strategy and audit readiness across all regulated environments
- Lead AI regulatory intelligence e.g. FDA, EMA, EU AI Act and emerging global frameworks, coordinated with Legal and business units to get ahead of compliance obligations
- Partner at the executive level with Legal, Compliance, Regulatory Affairs, and CISO on regulatory interpretation, risk posture, and technical standards

**This role might be for you if you:**

- Have led AI governance or technical risk functions in a complex, regulated industry and built the teams that execute them
- Bring technical depth to set strategy and leadership range to hire and hold accountable the experts who implement it
- Understand the distinct risk profiles of predictive, generative, and agentic systems and have governed them in production
- Have driven GxP AI validation strategy in a life sciences or biopharma setting
- Stay ahead of FDA AI/ML guidance, EU AI Act, and emerging frameworks and convert them into enterprise action
- Operate with credibility at the engineering level and the board level
- See AI governance as a strategic capability that accelerates the business and build it that way

**This role requires:**

- A Bachelor's degree in a related field (advanced degree required for certain scientific or clinical positions)
- 17+ years of experience in AI governance, risk management, regulatory affairs, or compliance

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$255,000.00 - $424,900.00

New York

Eli Lilly and Company

Executive Director - Clinical Research Physician - GPS Medical

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Clinical Research Physician, GPS Medical

**Purpose**

The Clinical Research Physician (CRP) in GPS Medical has responsibilities associated with the development, management, execution, and oversight of all aspects of the safety program for one (or more) asset(s) throughout the product(s’) life cycle. This individual plays a major role in coordinating technical functions within GPS to facilitate these responsibilities. The individual is accountable for collaborative contributions and partnership with the integrated development or product team to deliver on these safety commitments while demonstrating GPS expertise and leadership.

The CRP is the Lilly GPS Medical representative for both internal and external stakeholders regarding a product or developmental therapeutic agent, interacting as prescribed in corporate guidelines, standards, and policies. Individualized responsibilities for a particular product or project will be discussed and agreed at an individual level.

**Primary Responsibilities**

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Not all listed responsibilities will be applicable to all GPS Medical CRP roles.

1. Key GPS Medical Activities and Safety Oversight

▪ Provides GPS Medical leadership and ensures proactive pharmacovigilance (PV) for assigned product(s):

i. In early phase development, performs and/or contributes to medical review of individual case safety reports for completeness and accuracy, providing company causality assessment and requests for follow up, if needed.

ii. Provides medical oversight of surveillance activities, safety signal decisions and risk management actions to be taken, including communication and/or escalation to appropriate internal or external stakeholders (e.g., GPS leadership, governance committees, development teams, Regulators)

iii. Monitors various safety activities for impact to Core Safety Information and Core Risk Minimization activities i

v. Builds collaborative working relationships to ensure full cooperation; guides effective and efficient drug development, and ensures high-quality medical evaluation of safety data

v. Responsible for the oversight and actions related to regulatory queries on safety-related topics

▪ Acts as the GPS Medical lead at the time of acquisitions and integrations of new companies/assets, partnering with internal and external stakeholders to ensure seamless continuity of safety surveillance activities.

▪ Demonstrates advanced knowledge of safety concepts, per ICH, US and international regulation/guidelines and GxP.

▪ Synthesizes complex data into actionable insights and translates technical issues into strategic discussions

2. Acts as the Lilly GPS Medical Representative for both internal and external stakeholders, interacting as prescribed in corporate guidelines and policies.

▪ Builds strong relationships with key stakeholders, representing and championing the role of safety in the organization (including):

i. Product Team Leaders and Business Unit Leadership

ii. Regulatory (including Device and CMC regulatory)

iii. Affiliate Medical Leadership/Clinical Research Physicians

iv. COE and Discovery and Clinical Research

v. External Opinion Leaders

▪ Reviews and comments on external regulatory policy and trends affecting Global Patient Safety.

▪ Represents GPS Medical in inspection and audit activities for assigned program(s)

▪ May serve on safety advisory hub committees and/or consultative cross-functional bodies providing input and guidance to clinical development teams on select safety topics

▪ May serve as a member of the Quality-GPS (AE/PC and Device) safety surveillance teams evaluating aggregate product complaint/adverse event data for potential manufacturing quality related safety signals

3. Product Safety Assessment

• Provide the sound and timely medical assessment decision making for the safety questions based on current medical and scientific data in collaboration with cross-functional partners for the following:

i. Product Safety Assessments (PSAs), Health Hazard Evaluations (HHEs), and other risk assessment documentation

ii. Device design, development, risk management, and periodic reporting

iii. CMC development, manufacturing changes, CMC submissions and CMC regulatory requests,

iv. Company anticounterfeiting activities, product shortage evaluations, quality triage escalation activities and regulatory reporting.

▪ Provide clinical evaluation of individual adverse events for possible manufacturing-related root cause for Lilly products

▪ Responsible for appropriate implementation of PSA/HHE process with manufacturing and/or marketing partners.

▪ Prepare medical complaints in response to signals identified during AE/PC and Device Surveillance.

▪ Review and approve/reject manufacturing investigation results in response to medical complaints, including escalation as needed for any identified manufacturing related safety issues.

▪ Proactive monitoring to evaluate for unanticipated safety impacts related to deviations addressed by HHEs

4. People Management

▪ Foster and support a collaborative working environment that maintains a Team Lilly culture focused on inclusion, innovation, acceleration, and delivery

▪ Recruit, mentor, develop, and retain top clinical, scientific, and drug development talent, including clinical research physicians, clinical research scientists, and pharmacoepidemiologists.

▪ Assures staff comply with company policies and procedures

5. Understand and support the QPPV role

▪ Understanding the roles and responsibilities of the European Union Qualified Person (QPPV).

▪ Ensure support is provided to enable the Qualified Person to fulfill all the Qualified Person legal responsibilities.

6. Training, Coaching, Mentoring

▪ Provide training, coaching and mentorship demonstrating effective PV strategies and sharing experience and knowledge to further advance the goals of the GPS department and wider enterprise.

▪ Maintain compliance with Lilly Red Book and corporate policies, Lilly Research Laboratories and Global Patient Safety curriculum.

▪ Maintaining compliance with the Lilly Corporate Integrity Agreement.

7. A Clinical Research Physician, GPS Medical is expected to meet the criteria as outlined in the global path job criteria for the appropriate R path levels.

▪ For each level on every global path, there is a consistent set of job criteria which includes functional and technical expertise, decision making, influence, and problem solving.

**Minimum Qualification Requirements:**

▪ Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring.

▪ US trained physicians must have achieved board eligibility or certification. Foreign medical graduates (in US based jobs) who are not US board eligible or certified may be hired directly for employment in the US at the discretion of the Chief Medical Officer.

▪ Non-US trained physicians must have completed education and training at a medical school that meets the minimum requirements substantially equivalent to the requirements of medical schools accredited by the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see[PLA: Physicians Licensing Information and Medical Education](<http://www.in.gov/pla/2799.htm>) | MBC

▪ Minimum 3+ years’ experience in the pharmaceutical industry or clinical care setting.

**Other Information/Additional Preferences:**

▪ Prior experience in clinical trials preferred; academic and/or industry.

▪ Clinical development or pharmacovigilance experience preferred

▪ Knowledge of drug development process

▪ Fluent in English with highly effective written and verbal communication skills

▪ Strong clinical/diagnostic skills

▪ Excellent interpersonal, organizational and negotiation skills

▪ Ability to work on multiple projects and function effectively in a fast-paced matrixed environment

▪ Ability to prioritize tasks and shift priorities rapidly to meet tight deadlines

▪ Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment

▪ Excellent teamwork skills

▪ Willing to engage in domestic and international travel to the degree appropriate to support the business of the team

▪ Knowledge of global pharmacovigilance guidelines, guidance, and regulations (EMA, FDA, etc.) relevant to the activities and responsibilities described above Strategic thinking

▪ Demonstrated success in implementing projects and/or innovating

▪ Receptive, engaging, and impactful contributor

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$243,000 - $356,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Indiana

Sanofi US

GRA Global AdPromo Excellence Lead

**Job title**: GRA Global Ad-Promo Excellence Lead

**Location**: Morristown, NJ, Cambridge, MA.

**About the job**

A hybrid role combining support for global promotional material regulatory review (30%) with transversal excellence activities (70%). The position supports innovation, and operational efficiency across the GRA Advertising and Promotion (GRA Ad-Promo) organization while maintaining hands-on review expertise to ensure strategic initiatives remain grounded in operational realities.

Join the engine of Sanofis mission where deep immuno-science meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

**About Sanofi**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world and are supported and enhanced through our diverse portfolio of medical device and diagnostic products. Together, we chase the miracles of science to improve peoples lives.

**Main Responsibilities**

**Global Ad-Promo Regulatory Review (~30%)**

- Work closely with the assigned global business units (commercial and medical) in the development of promotional / non-promotional materials, their review and prior approval. This also includes the review of internal and external documents issued by communication when related to products/diseases.

- Act as an advisor for the team regarding the review of promotional activities on global level and/or for the local affiliates;

- Review the regulatory aspects (as indicated in the Sanofi Global internet rules) of internet websites and social media (global).

- Define the minimal quality standard and processes to be applied worldwide. Support the set up of guidelines / Quality documents on topics related to regulatory requirements around promotional aspects to ensure appropriate communication to the relevant stakeholders;

- Advise teams on evolving regulatory requirements, industry trends, enforcement actions and complaints related to pharmaceutical advertisingand promotion

**Excellence Support Activities (~70%)**

**Innovation & Transformation Support**

- Represent GRA Ad-Promo in transformation programs and cross-functional initiatives
- Support the evaluation and testing of digital tools and Gen AI use cases under guidance from the Excellence Head
- Help compile data and observations for system and process reviews

**Stakeholder Coordination**

- Support coordination activities with transversal partners and regional teams
- Assist in preparing materials and communications for stakeholder meetings and updates
- Advocate for the Ad-Promo team's strategic value and priorities

**Operational Excellence Support**

- Assist with data collection and documentation for gap analyses of regulatory processes
- Support maintenance of KPI reporting and dashboards by gathering and organizing relevant data
- Help document best practices, process updates, and SOP revisions under senior guidance

**Training & Capability Building Support**

- Assist in the preparation process documentation for both transversal and regulatory
- Help maintain and update global training materials
- Conduct upskilling sessions with (regional) regulatory teams on digital initiatives

**Governance & Ways of Working Support**

- Provide administrative and coordination support for GRA Ad-Promo Governance activities
- Assist in team engagement activities such as town halls and workshops

**About you**

**Basic Qualifications**

**Education**

- BA/BS degree in Pharmaceutical Sciences, Life Sciences, or a related discipline (e.g., Chemistry, Biology, Biochemistry, Pharmacology, Biomedical Sciences, Public Health) OR
- Candidates with degrees outside these fields will be considered provided they have 2+ years of direct experience in biopharma regulatory affairs, regulatory advertising and promotion review or related functional areas.

**Experience**

- 2+ years of experience in the biopharmaceutical industry supporting regulatory affairs, regulatory advertising and promotion review or similar functional areas.

**Preferred Technical & Soft Skills**

- Good understanding of global codes and standards including ability to review against the EFPIA and IFPMA standards
- Interpret complex clinical data (eg, CSRs, medical publications)
- Possesses sufficient scientific and clinical knowledge to understand disease states, mechanisms of action, clinical trial design, and statistical concepts relevant to the products being reviewed.
- Use data and local SmPC to inform compliant messaging
- Understand review standards for branded, disease awareness, and medical congress content
- Experience supporting transversal and/or digital transformation initiatives like Gen AI, Modular Content, Core Claims, and or other MLR programs.
- Familiarity with regulatory technology systems such as Veeva and basic familiarity with digital tools and platforms (e.g., Microsoft Office, SharePoint)
- Eagerness to learn and grow within regulatory affairs and excellence functions
- Strong attention to detail and commitment to quality in all tasks
- Foundational understanding of pharmaceutical regulatory concepts (or willingness to develop this quickly)
- Good organizational and coordination skills
- Clear and professional written and verbal communication
- Collaborative mindset with the ability to work effectively within a team
- Adaptable and proactive in a fast-paced, evolving environment

**Language**

- English (fluent required); additional languages beneficial.

**Why choose us?**

Bring the miracles of science to life alongside a supportive, future-focused team.

Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.

Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs.

Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

Help improve the lives of millions of people globally by making drug development quicker and more effective.

Enjoy opportunities to collaborate beyond your area of expertise, working with diverse teams across science, clinical, and digital fields to spark new ideas and drive breakthroughs.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; colour; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

\#GD-SG

\#LI-GZ

\#LI-Onsite

\#vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>)

Massachusetts

Sr. Director - ExploR&D Regulatory Writing and Capabilities

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’**

wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.

Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.

Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!

**Organization Overview**

Lilly Catalyze360 is a comprehensive approach to enabling the early-stage biotech ecosystem by democratizing access to infrastructure, expertise, and resources. Through its interconnected pillars—Lilly Ventures, Lilly Gateway Labs, Lilly ExploR&D, and Lilly TuneLab—Catalyze360 strategically removes barriers that traditionally block bold science from becoming life-changing medicines, providing biotechs with flexible combinations of capital, physical lab space, R&D capabilities, AI/ML tools, and decades of enterprise learning.

Lilly ExploR&D is a team of drug discovery and development experts who partner with biotechs from discovery through clinical proof-of-concept, putting Lilly's industry-leading capabilities behind their missions. We provide flexible support—from strategic consulting to full program execution—making it faster, easier, and more capital-efficient for innovators to transform bold science into life-changing medicines.

**Job Summary**

The Senior Director will lead the regulatory and medical writing function within ExploR&D, overseeing the preparation and delivery of clinical and regulatory documents and development of IT tools to support the document writing needs of ExploR&D and our partners. The Senior Director will be responsible for business process management, vendor management, systems management, systems implementation, and emerging technology implementation. The Senior Director will provide strategic, tactical, and technical/operational direction, and lead writing deliverables and strategies across the ExploR&D portfolio.

The Senior Director collaborates with cross-functional, multidisciplinary teams, including internal and external stakeholders, to produce high-quality regulatory and scientific documents intended to support regulatory interactions, clinical trial execution, and external partner’s strategies.

The Senior Director is responsible for coordinating content across complex documents, ensuring accuracy, compliance, and clarity. These documents may include preclinical, clinical and regulatory documents (such as protocols, investigator’s brochures, clinical study reports, briefing documents, regulatory responses, Target Product Profiles, regulatory strategy documents, and Integrated Development Plans), global clinical trial applications (IND/CTA documents), and external scientific publications (such as abstracts, posters, manuscripts, and presentations).

**Key Responsibilities**

**Document Preparation and Management**

- Lead cross-functional teams to ensure timely development of writing deliverables

- Manage and track workload; escalate resource capacity issues as needed

- Plan, write, edit, review, and strategically coordinate complex regulatory documents, development strategies, and scientific publications

- Oversee and coordinate quality review and finalization of documents

- Provide expertise on databases and other tools necessary to perform work (such as document management systems)

**Consultancy on Behalf of ExploR&D**

- Represent ExploR&D in assigned projects, interacting directly with biotech partners

- Strategically build and manage relationships with biotech partners and vendors

- Serve as an expert for ExploR&D portfolio and associated asset development, as it pertains to medical writing activities and related expertise

- Contribute to the identification, prioritization, and assessment of collaboration opportunities

- Maintain and enhance knowledge of regulatory and publication guidelines

- Network with Lilly functions to share best practices

**Capability Building and Strategic Leadership**

- Build a suite of AI writing capabilities to increase efficiency within ExploR&D, working with internal experts and external vendors

- Identify, evaluate, develop, and implement systems and tools that increase efficiency and streamline document development, such as AI Authoring tools, automation tools and document management systems

- Allocate medical writing resources to support incoming projects

- Support ExploR&D’s strategic direction by implementing document standards, workflows, and priorities in support of the portfolio

- Identify and implement improvements in writing processes, standard operating procedures (SOPs), and templates to ensure they are fit for purpose

**People Development**

- Provide informal coaching to others by sharing technical information, giving guidance, and answering questions

- Support cross-functional coaching, mentoring, and training

- Train, coach, and mentor staff to deepen their medical writing expertise, improve communication skills, and build strong relationships across ExploR&D functions and with external partners (this may be through direct or indirect reporting relationships, as assigned)

- If assigned, recruit, develop, and retain an operationally capable workforce skilled in medical writing and its application in clinical development

- Champion a commitment to quality and safety

- Support a culture that fosters inclusion, innovation, and judgement-based decision making

**Minimum Requirements**

Education:

- Advanced graduate degree (PharmD, PhD, MD) in a health-related or scientific field

Experience:

- At least 7 years’ of experience in the pharmaceutical industry in two or more of the following areas: preclinical development (PK/PD, pharmacology, toxicology), clinical development, CMC, regulatory affairs, regulatory writing.

- Demonstrated mastery of written English with at least 3 years’ experience in writing regulatory, clinical trial documents, and/or scientific publications.

Additional Skills and Preferences:

- Experience in clinical trial process and/or regulatory activities.

- Deep understanding of investigational product requirements, especially GCP and GLP regulations.

- Demonstrated leadership in managing document development for various document types/indications.

- Experience in managing external partnerships/vendor relationships.

- Exceptional critical thinking, strategy development, and decision-making skills.

- Demonstrated ability to influence strategies and proven ability to deliver results in a complex or ambiguous environment.

- Demonstrated project management and time management skills.

- Demonstrated strong leadership and team management skills.

- Experience as a direct supervisor or leading cross-functional teams preferred.

- Strong interpersonal skills and the ability to be flexible in varying environments and with multiple customer groups.

- Demonstrated high-level end-user computer skills (such as word processing, working with tables and graphics, spreadsheets, presentation and templates).

- Experience in use, development or implementation of automation tools and software solutions, including AI-driven tools to streamline document creation and development process.

- Ability to work well across cultures and time zones.

**Additional Information**

- Location: Cork, Ireland; Indianapolis, IN; San Francisco Bay Area, CA; San Diego, CA; Boston/Cambridge, MA; or remote (US) with quarterly travel to Indianapolis. Relocation is not provided.

- Travel up to 10% US and/or OUS

- A writing exercise may be required as part of the candidate evaluation process. Writing samples may be requested.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

€93,000 - €136,400

Full-time equivalent employees may also be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a pension plan; vacation benefits; eligibility for healthcare benefits; flexible benefits (if applicable) life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLillyUKandIreland

Externally Sponsored Research Manager

**Job Title:** Externally Sponsored Research Manager

- Location: Cambridge, MA

**About the job**

Within Sanofi, we are committed to supporting medically and scientifically sound research aimed at the advancement of disease knowledge and potential treatments in therapeutic areas of interest to Sanofi with the goal of advancing patient care. Sanofi receives, reviews, and responds to unsolicited proposals from health care professionals (HCPs), scientists, and researchers or institutions (i.e. external sponsor) for Externally Sponsored Research (ESR) support, including Investigator Sponsored Studies (ISS) and Externally Sponsored Collaborations (ESC).

The ESR Manager is responsible for operational oversight of unsolicited research support requests submitted through the company web portal, to ensure they are appropriately routed for scientific review. This position will ensure timely and compliant study review, start-up, execution, completion, and tracking of key research milestones as per research agreement, for ESR approved by the Scientific Review Committee (SRC).

The role reports directly to the Sanofi Senior Manager, ESR Operations.

We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities.

We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

**About Sanofi**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

**Main Responsibilities**

- Manages the overall study operational activities for all ESRs from initial proposal submission to study closeout including (but not limited to) SRC management, tracking ESR performance, supply management, contracting, obtaining regulatory documentation and cross-reference letters, transfer of value reporting, tracking payments, and overall ESR program reporting.
- Executes all ESR process-related activities compliantly per Sanofi SOPs, policies & procedures and local laws& regulations. Contributes to program audit readiness and provides accurate and rapid responses to audit inquiries.
- Collaborates cross-functionally to ensure efficient and timely delivery of research agreements, product supply, purchase orders and other deliverables.
- Collaborates closely with SRC providing necessary information and support to ensure compliant, timely, efficient reviews of concepts, study outlines, protocols, and protocol
- amendments.
- Supports the development of metrics, KPIs and other business analytics to measure
- progress and inform investment decisions; ensures study updates are collected, documented, tracked, and communicated to stakeholders.
- Oversees ESR system of record; maintains data integrity by enforcing standards, controls & permissions. Works with system vendor and Systems & Process Ops team on issue resolution and enhancements.
- Collaborates with Product Supply teams to ensure product demand forecasts are maintained and updated to reflect current needs for adequate supply of active studies.
- Collaborates and provides information for CMO reporting and cross-GBU initiatives related to ESR.
- Supports dissemination of safety updates and Dear Investigator Letters (DILs).
- Ensures stakeholders are trained and have access to ESR system of record and other
- ESR related tools.

**About you**

Basic Qualifications

- **Education:**  Bachelor's degree in life sciences or a related scientific discipline
- **Experience:**  Minimum 2 years of relevant experience in clinical operations, hospital settings, pharmaceutical, or another regulated medical environment

Preferred Qualifications

- Project management experience, certification (e.g., PMP) is a plus

- Familiarity with Investigator Sponsored Studies program requirements and the external regulatory environment (e.g., GCP, ICH standards, compliance codes)
- Proven track record of driving efficiency in processes
- Ability to proactively anticipate obstacles and work independently with minimal direction
- Experience managing diverse stakeholders across different functions and seniority levels
- Strong verbal and written communication skills
- Strong quantitative, analytical, and problem-solving skills
- Proven cross-functional collaboration skills across multiple teams and seniority levels

**Why choose us?**

- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.
- Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
- Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
- Help improve the lives of millions of people globally by making drug development quicker and more effective.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

\#GD-SG

\#LI-GZ

\#LI-Onsite

\#vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>)

**Job Title:Externally Sponsored Research Manager**

- Location: Morristown, NJ

**About the job**

Within Sanofi, we are committed to supporting medically and scientifically sound research aimed at the advancement of disease knowledge and potential treatments in therapeutic areas of interest to Sanofi with the goal of advancing patient care. Sanofi receives, reviews, and responds to unsolicited proposals from health care professionals (HCPs), scientists, and researchers or institutions (i.e. external sponsor) for Externally Sponsored Research (ESR) support, including Investigator Sponsored Studies (ISS) and Externally Sponsored Collaborations (ESC).

The ESR Manager is responsible for operational oversight of unsolicited research support requests submitted through the company web portal, to ensure they are appropriately routed for scientific review. This position will ensure timely and compliant study review, start-up, execution, completion, and tracking of key research milestones as per research agreement, for ESR approved by the Scientific Review Committee (SRC).

The role reports directly to the Sanofi Senior Manager, ESR Operations.

We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

**About Sanofi**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

**Main Responsibilities**

- Manages the overall study operational activities for all ESRs from initial proposal submission to study closeout including (but not limited to) SRC management, tracking ESR performance, supply management, contracting, obtaining regulatory documentation and cross-reference letters, transfer of value reporting, tracking payments, and overall ESR program reporting.
- Executes all ESR process-related activities compliantly per Sanofi SOPs, policies & procedures and local laws& regulations. Contributes to program audit readiness and provides accurate and rapid responses to audit inquiries.
- Collaborates cross-functionally to ensure efficient and timely delivery of research agreements, product supply, purchase orders and other deliverables.
- Collaborates closely with SRC providing necessary information and support to ensure compliant, timely, efficient reviews of concepts, study outlines, protocols, and protocol amendments.
- Supports the development of metrics, KPIs and other business analytics to measure progress and inform investment decisions; ensures study updates are collected, documented, tracked, and communicated to stakeholders.
- Oversees ESR system of record; maintains data integrity by enforcing standards, controls & permissions. Works with system vendor and Systems & Process Ops team on issue resolution and enhancements.
- Collaborates with Product Supply teams to ensure product demand forecasts are maintained and updated to reflect current needs for adequate supply of active studies.
- Collaborates and provides information for CMO reporting and cross-GBU initiatives related to ESR.
- Supports dissemination of safety updates and Dear Investigator Letters (DILs).
- Ensures stakeholders are trained and have access to ESR system of record and other ESR related tools.

**About you**

Basic Qualifications

- **Education:**  Bachelor's degree in life sciences or a related scientific discipline
- **Experience:**  Minimum 2 years of relevant experience in clinical operations, hospital settings, pharmaceutical, or another regulated medical environment

Preferred Qualifications

- Project management experience, certification (e.g., PMP) is a plus

- Familiarity with Investigator Sponsored Studies program requirements and the external regulatory environment (e.g., GCP, ICH standards, compliance codes)
- Proven track record of driving efficiency in processes
- Ability to proactively anticipate obstacles and work independently with minimal direction
- Experience managing diverse stakeholders across different functions and seniority levels
- Strong verbal and written communication skills
- Strong quantitative, analytical, and problem-solving skills
- Proven cross-functional collaboration skills across multiple teams and seniority levels

**Why Choose Us?**

- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.
- Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
- Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
- Help improve the lives of millions of people globally by making drug development quicker and more effective.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

\#GD-SG

\#LI-GZ

\#LI-Onsite

\#vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>)

New Jersey

Senior Corporate Counsel, Patient Support Services and Diagnostic Testing

**Job Title**: Senior Corporate Counsel, Patient Support Services and Diagnostic Testing

- Location: Morristown, NJ

**About the Job**

We are seeking an experienced attorney with relevant industry experience to join the Sanofi North America Legal team as Senior Corporate Counsel, Patient Support Services & Diagnostic Testing. This role will provide comprehensive legal support to business colleagues at all levels within the commercial operations for Sanofi's Patient Support Services (PSS) and Diagnostic Testing programs.

This role supports both day-to-day operations and long-term strategies, with a focus on securing patient access to Sanofi medicines and supporting Sanofi's product portfolio. The ideal candidate will also have the interest and flexibility to support other parts of the business as needs arise.

Ready to push the limits of whats possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world.

**About Sanofi:**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

**Main Responsibilities**

*Patient Support Services & Diagnostic Testing:*

- Serve as the primary legal contact for patient support programs and diagnostic testing initiatives, acting as the liaison among business colleagues and all other relevant legal functions (e.g., product support attorneys, market access legal, transversal operations, and compliance)
- Draft, negotiate, and finalize contracts required for implementation of patient support programs (including free drug programs, copay programs, reimbursement services) and diagnostic testing programs
- Advise business partners on the design, launch, and ongoing operation of patient support and diagnostic testing programs, including copay and patient assistance programs, risk mitigation, and customer interactions
- Review external materials for content related to patient support and diagnostic testing programs
- Collaborate with colleagues in the US Privacy Office and Ethics & Business Integrity on relevant privacy and compliance workstreams, act as NA Legal Department representative on relevant privacy workstreams, and coordinate implementation of related initiatives

*Cross-Functional Responsibilities:*

- Work with business colleagues to assist them with adherence to Sanofi's policies and understand legislative, enforcement, and regulatory developments that may impact Sanofi's patient support and diagnostic testing programs
- Ensure client operations comply with applicable laws and company policies, including the Anti-Kickback Statute and other US healthcare compliance laws
- Develop and conduct training for internal teams on compliance and policy development topics
- Analyze initiatives, advisory board proposals, and field-based activities for fraud and abuse, FDA, and other regulatory compliance
- Engage with commercial partners across functions including sales, medical, regulatory, operations, finance, supply chain, manufacturing, pharmacovigilance, and external affairs

**About You**

**Basic Qualifications**

*Education & Experience:*

- JD and a license to practice law in at least one US jurisdiction (New Jersey or Massachusettspreferred)
- Minimum of 7 years of legal experience, preferably including both law firm and in-house experience in the pharmaceutical, biotechnology, or medical device industry
- Experience working in a matrix, international environment

*Professional Knowledge:*

- Substantive working knowledge of US Federal and state laws and regulations relating to the pharmaceutical industry, including the False Claims Act, Anti-Kickback Statute, and competition laws
- Strong understanding of the US healthcare system, including reimbursement and patient access
- Substantive working knowledge of the legal landscape that applies to patient support programs and diagnostic testing
- Experience drafting, interpreting and negotiating contracts with third parties, including vendors supporting patient support and diagnostic testing programs

*Professional Skills:*

- Strong contract drafting and negotiation skills with third parties
- Ability to provide and effectively communicate sound legal advice coupled with a strong understanding of business needs
- Flexibility to manage multiple subject matter issues across diverse areas of the company, taking the initiative to identify appropriate subject matter experts and coordinating overall review
- High degree of organizational skill and attention to detail
- Comfortable engaging in proactive counseling and thoughtful risk-taking
- Ability to be decisive, especially in ambiguous situations
- Demonstrated excellence in understanding complex scenarios, proposing solutions that consider business objectives, and communicating issues clearly
- Sound judgment and commitment to ethical conduct
- Strong interpersonal skills with a solution-oriented approach
- Self-motivated, reliable, responsive, and accountable
- Ability to manage outside counsel effectively and efficiently
- Willingness to adapt job responsibilities and learn new areas as needed, including but not limited to US Market Access and Product Support

**Why Choose Us?**

- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.
- Make your work count by supporting a company that brings life-changing treatments to millions and is committed to doing right by patients, communities, and the planet.
- Drive progress from within by helping simplify, scale, and modernize how a global biopharma business delivers smarter, faster, and more sustainably
- Support teams across science, medicine, and operations by building better systems, shaping bold strategies, and enabling innovation at speed

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

\#GD-SA

\#LI-SA

\#vhd

\#LI-Hybrid

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>)

Regulatory Site Officer

**Job Title: Regulatory Site Officer**

- Location: Swiftwater, PA

**About the Job**

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

The Regulatory Site Office, Vaccines will work closely with the Manufacturing and Supply teams and CMC colleagues on Vaccines based projects to achieve submissions and approvals in key markets and to maintain regulatory compliance for License registrations. The RSO management and position are based in Swiftwater, PA USA. This is a hybrid position.

**About Sanof**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

**Main Responsibilities**

The RSO within the Regulatory Site Office supports regulatory compliance for marketed products by means of compliant and timely handling of regulatory activities at Swiftwater. The incumbent manages change control assessments and regulatory activities linked to change controls for the site, including the update of CMC files. These accountabilities include:

- Change Control Assessments
- PLC Management
- Authoring the variations, the CTD sections impacted by the changes, and the renewals of the site products registrations, in compliance with all applicable regulations and company processes
- Maintaining and updating regulatory files and databases
- Defining the potential regulatory impacts of changes made to the site products and services
- Ensuring compliance of the site products with all relevant product registrations, laws, regulations, standards, and guidelines in the markets where the site operates
- Assisting in internal and external audits, including regulatory inspections

**About You**

**Basic Qualifications**

- Bachelor's Degree
- 3 + years' experience in regulatory affairs, change control or technical writing
- OR 10 years in GxP regulated fields

**Other Qualifications**

- Experience with regulatory preparation of CMC dossier
- Well-developed communication skills, both verbal and written
- In-depth understanding of regulatory requirements and guidelines relevant to the pharmaceutical industry
- Ability to analyze complex regulatory documents and data to ensure compliance and identify potential issues
- Demonstrates initiative, analytical thinking and works independently
- Proficiency in managing multiple regulatory projects simultaneously, ensuring timely submissions and compliance
- High level of accuracy and attention to detail in preparing and reviewing regulatory documents and reports
- Experience working with a Health Authority is helpful but not essential

**Why choose us?**

- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.
- Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
- Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale
- Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

\#GD-SP

\#LI-SP

\#LI-Onsite

\#Vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>)

Pennsylvania

Patent Counsel, Biologics - Global Intellectual Property

**Job Title**: Patent Counsel, Biologics - Global Intellectual Property

- Location: Cambridge, MA

**About the Job**

The Counsel will be an experienced patent attorney responsible for biologics projects on a talented team committed to diversity and inclusion. The attorney will be part of the US team dedicated to all aspects of patent protection for a diverse range of programs across Sanofi's business units. The attorney will advise on wide range of intellectual property matters, including patent preparation and prosecution, worldwide patent portfolio management, overall IP strategy including loss-of-exclusivity (LOE) strategies, PTE/SPC strategies, patentability assessments, and freedom-to-operate (FTO) analyses including risk mitigation strategies.

The position reports directly to the principal leader of US Biologics Patents and is located in Cambridge, Massachusetts.

Ready to push the limits of whats possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world.

**About Sanofi:**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

**Main Responsibilities**

The Counsel, Biologics Patents will be responsible for all aspects of patent protection for assigned biologics programs. Principal accountabilities include:

- Prepare, draft, file, and prosecute US, EPO, and foreign patent applications across biotechnology and biologics areas.

- Interact with internal clients including Research & Development, Project Management, Business Development, Franchise, CMC, and Industrial Affairs in the US and Europe on a regular basis, providing proactive IP counselling and soliciting invention disclosures.

- Proactively advise clients on IP strategy aligned with business objectives, including portfolio positioning and competitive landscape, preferably using AI-enhanced portfolio analytics, competitive intelligence, and predictive modeling, and translating complex data into actionable business recommendations.

- Provide patentability evaluations of IP related to internal research programs and external business development opportunities.

- Conduct, direct, and analyze patent searches; render written opinions on validity, non-infringement, and freedom-to-operate / design-around of third-party patents.

- Initiate, defend, and manage post-issuance proceedings, including US Inter Partes Review (IPR), Post-Grant Review (PGR), EPO Oppositions, and patent litigation support.

- Review proposed research papers and other publications for potential impact on Sanofi's existing patent estate.

- Participate in the drafting, reviewing, and negotiation of agreements covering intellectual property rights (licenses, CDAs, collaboration agreements, etc.)

- Leverage AI tools strategically across the full patent lifecycle including AI-assisted drafting, claim analysis, prior art searching, office action response preparation, and portfolio analytics while maintaining critical oversight, professional judgment, and work product quality control.

- Critically review and validate all AI-generated work products to ensure technical accuracy, legal soundness, strategic alignment, and freedom from hallucinations or analytical errors before client delivery or filing.

- Direct AI-assisted workflows for patent prosecution streams, configuring AI tools to execute within defined strategic parameters while maintaining appropriate human oversight for privilege, risk management, and client accountability.

- Develop custom AI tools and workflows to address emerging needs in patent prosecution, IP strategy, or portfolio management including prompt engineering, automation of routine analysis, and creation of bespoke intelligence tools (e.g., examiner behavior analysis, art unit trend mapping) without waiting for vendor or IT solutions.

- Collaborate with cross-functional teams to identify opportunities for AI augmentation of IP processes, pilot new AI capabilities, and share best practices for responsible and effective AI integration across the Global IP organization.

- Maintain professional accountability and licensed judgment as the human decision-maker in all AI-augmented work, ensuring that AI serves as a force multiplier for strategic thinking rather than a substitute for legal expertise or client counseling.

- Serve as a thought leader within the Global IP team on responsible AI adoption, sharing insights on effective AI integration, emerging risks, and evolving best practices for AI-augmented patent practice.

- Develop and maintain an effective professional network within Sanofi's Biologics Business Units and Global IP group.

**About You**

**Basic Qualifications**

- Graduate degree (M.S. or Ph.D.) in biological or biochemical science; a Ph.D. is strongly preferred.

- A motivated, self-starting professional who takes initiative and contributes to the team beyond the scope of assigned projects.

- Registered US Patent Attorney and member of at least one US State Bar, and/or qualified European Patent Attorney (having passed the EQE) or equivalent qualification in the relevant jurisdiction.

- Minimum 3-5 years of patent law experience, gained in-house at a biopharmaceutical or biotechnology company and/or at a law firm with life sciences practice.

- Confirmed, hands-on experience handling complex biologics IP matters, including therapeutic biological molecules such as monoclonal antibodies, multi-specific antibodies, NNANOBODY molecules, peptides, nucleic acids, cytokines, and/or enzymes.

- Demonstrated ability to independently manage the preparation and prosecution of patent applications from drafting through grant.

- Excellent written and oral communication skills, with the ability to convey complex IP concepts clearly to both legal and non-legal audiences.

- Proven ability to work effectively within a global, cross-functional team and to build relationships across geographies and disciplines.

- Demonstrated AI fluency in a legal or technical professional context, including hands-on experience using AI tools for patent drafting, prosecution, or IP analysis.

- Proven ability to assess AI-assisted work products, with the critical judgment to evaluate, verify, and challenge AI-generated outputs, including identifying errors, hallucinations, or analytical gaps in AI-generated responses, claim drafts, or prior art analyses.

- Comfort operating in a technology-forward work environment, with a disposition to continuously adopt, evaluate, and integrate emerging AI tools into daily practice.

**Preferred Qualifications:**

- Ph.D. in biological or biochemical science.
- Experience managing EPO Oppositions, US IPR/PGR proceedings, and/or patent litigation.
- Prior in-house experience at a biotech or biopharma company.
- Familiarity with French, German, and/or Dutch (Flemish) is an asset.
- Experience with IP aspects of licensing, M&A due diligence, or business development transactions.
- Experience with biologics platform technologies, including antibody formats, gene therapy, bioprocesses, formulations, and/or drug-device combinations.
- Solid foundational knowledge of chemistry as it relates to biologics and biochemistry.
- Ability to orchestrate and direct AI-assisted workflows across concurrent prosecution streams, including configuring AI tools to execute within a defined strategic framework while maintaining appropriate human oversight and privilege considerations, and managing AI agents and human collaborators to deliver high-quality IP outcomes at scale while adapting in real-time to unexpected developments.
- Experience or demonstrated aptitude for building or customizing lightweight AI tools or workflows (e.g., prompt engineering, no-code/low-code automation, or custom GPT configurations) to address gaps in patent prosecution or IP analysis workflows without reliance on IT or vendor support.

**Why Choose Us?**

- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.
- Make your work count by supporting a company that brings life-changing treatments to millions and is committed to doing right by patients, communities, and the planet.
- Drive progress from within by helping simplify, scale, and modernize how a global biopharma business delivers smarter, faster, and more sustainably
- Support teams across science, medicine, and operations by building better systems, shaping bold strategies, and enabling innovation at speed

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

\#GD-SA

\#LI-SA

\#vhd

\#LI-Hybrid

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>)

People Business Partner Research and Development North America

**Job Title:**  *People Business Partner Research and Development North America*

- **Location:** *Cambridge, MA*

**About the job**

The People Business Partner, R&D North America acts as the key focal point for all people ((\> 2,500 R&D employees) and organization related topics and works as a strategic partner and advisor to the relevant R&D global and local business leaders. The role reports into the Global Head of People & Culture R&D and is part of the global R&D P&C leadership team and of the Sanofi North America P&C leadership team. It focuses on translating global R&D and P&C strategy into concrete people and organization objectives across the geography in scope.

Ready to push the limits of whats possible? Join Sanofi in one of our corporate functions and you canplay a vital part in the performance of our entire business while helping to make an impact on millionsaround the world

**About Sanofi**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

**Main Responsibilities**

- Talent Management: Drive the talent agenda with business leaders in scope, establishing talent reviews and high-quality succession plans for roles up to and including L5 for overall R&D across North America.
- Support business strategy: advises and guides the NA-based R&D teams on the execution of the R&D business strategy in close alignment with the Global BPs of the corresponding R&D functions and Sanofi NA P&C, as necessary
- Employee Relations: Manages communication and execution of organizational initiatives, establishing a trustful relationship with the respective stakeholders, manages individual employee relations issues -all with the support of People Excellence, People Services and Legal functions, as necessary
- People Strategy: Bring to life the People & Culture agenda by advising, coaching and influencing business leadership teams across client groups in scope
- Operational and Strategic Workforce Planning: Contribute to global OWP and SWP for R&D by providing the country perspective for all departments in scope.
- Project Management and Delivery Drive & support the delivery of R&D People priorities in NA and coordinate in-country projects
- People Managers Development: Hold managers accountable for leading and developing their people through key development activities and use of available online tools and resources
- Insights - Leverage local people insights to drive local initiatives/projects and to provide voice of customer for any global initiatives.
- Culture and DEI - Promote Sanofi DEI and culture through in-country nitiatives (bringing to life and contributing legal and local culture lens)
- Complex case management (by exception)
- Proactively encourage all managers and employees to utilize available self-service tools and OneSupport

**About You**

- University Degree in Business Administration, HR Management, Labor Law, Psychology or comparable
- Fluent in English
- 10-15 years of professional People & Culture experience
- Strong experience of common People management processes (performance and reward, talent acquisition, development and succession planning) and related digital tools
- Strong business orientation, commercially minded
- Agility in acting within a globally integrated operating and working with seamlessly with global/local Leadership teams
- Ability to scope, plan and implement P&C projects including the appropriate change management support
- Experience in organizational design and development (e.g. Space to Lead)
- US labor law
- Structured and independent way of thinking and working, ability to work in a team, self- and situational awareness, ability to manage by influence, flexibility and resilience

**Why choose us?**

- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.
- Make your work count by supporting a company that brings life-changingtreatments to millions and is committed to doing right by patients,communities, and the planet
- Drive progress from within by helping simplify, scale, and modernize how aglobal biopharma business delivers smarter, faster, and more sustainably.
- Support teams across science, medicine, and operations by building bettersystems, shaping bold strategies, and enabling innovation at speed.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

\#GD-SA

\#LI-SA

\#LI-Hybrid

\#vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>)

2027 Spring Co op Neuroscience Research Cambridge MA

**Job Title:**  *2027 Spring Co-op R&D Neuro TA*

- **Grade:**  *Co-op*
- **Location:**  *Cambridge, MA*
- **Duration:**  *6 months*

**About the Job**

Looking to launch your career at the cutting edge of neuroscience research? Join Sanofi's **Neurology Therapeutic Area (Neuro TA)**  team for a hands-on, wet lab-intensive co-op experience focused on **Parkinson's disease research**. As a Spring Co-op, you will work directly alongside scientists supporting both **in vitro and in vivo studies**, contributing to real research that advances our understanding of neurodegeneration.

You will be an active contributor to day-to-day laboratory activities, supporting individual and team-level studies under the direct mentorship of your hiring manager. You'll gain exposure to the **full drug development process**, from target identification and lead optimization through key development milestones.

Ready to grow your skills while helping shape the future of healthcare? At Sanofi, youll be empowered to Early Careers learn, ask questions, and bring your ideas to life all while supported by inspiring mentors and collaborative teams.

**About Sanofi**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

**Main Responsibilities:**

- Perform **mammalian cell culture**, including iPSC-derived neuron and glia culture techniques
- Execute standard molecular and biochemical assays including **ELISA, MSD (Meso Scale Discovery) immunoassays, immunoprecipitation, Western blot, and RT-qPCR**
- Assist with **in vivo mouse studies**, including animal handling, basic dosing procedures (e.g., intraperitoneal injections), tissue collection, and sample processing
- Follow established protocols with precision and scientific rigor, maintaining **meticulous laboratory records** and documentation
- Collaborate with team members on both individual and group research projects
- Contribute to experimental design discussions and data documentation in alignment with Sanofi's scientific standards

**About You**

**Basic Qualifications:**

- Currently pursuing a master or PhD degree in biomedical, life sciences or related field with plans to graduate by fall 2028.
- Must be permanently authorized to work in the U.S. and not require sponsorship of an employment visa (e.g., H-1B or green card) at the time of application or in the future. Students currently on CPT, OPT, or STEM OPT usually require future sponsorship for long term employment and do not meet the requirements for this program unless eligible for an alternative long-term status that does not require company sponsorship.
- Must be enrolled in an accredited college or university throughout the duration of the co-op/internship.
- Must be able torelocateto the office location and work 40hrs/week, Monday-Friday, for the full duration of the co-op/internship.

**PreferredQualifications:**

- Demonstrated proficiency in mammalian cell culture techniques, including iPSC-derived neuron/glia culture.
- Hands-on laboratory experience in both *in vitro* and *in vivo* studies.
- Demonstrated proficiency with standard molecular and biochemical assays such as ELISA, MSD (Meso Scale Discovery) immunoassays, immunoprecipitation, Western blot, and Real-time quantitative PCR (RT-qPCR).
- Experience with *in vivo* mouse handling, basic dosing procedures (eg. intraperitoneal injections), and tissue collection.
- Meticulous record-keeping practices and strong attention to detail.
- Commitment to scientific rigor in experimental design and data documentation.
- Prior experience in a research laboratory setting (academic research, previous co-op positions, and etc).

**Why Choose Us**

- Bring the miracles of science to life alongside a supportive, future focused team.
- Stretch your skills through apprenticeships, internships, graduate programs, and international experiences that grow with you.
- Learn from inspiring mentors and collaborative teams while contributing to real projects that shape the future of healthcare.
- Build your future with access to the latest tools, digital innovation, and continuous learning that keep you ahead of the curve.

**Compensation**

The salary range for this position is **$45 -$57** hourly. All compensation will be determined commensurate with demonstrated experience.

\#LI-Onsite

\#vhd

null

Associate Director, Health Economics & Outcomes Research, Solid Tumors

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. As an Associate Director you will develop HEOR strategies and plans, conduct HEOR and RWE studies and develop publications and deliverables. We work closely with Market Access, Medical Affairs, Clinical Development, Commercial, Regulatory and other groups to ensure evidence needs are identified and addressed to demonstrate the value with a focus on solid tumors

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

Location: Sleepy Hollow, NY

**Discover your role:**

Develop and implement HEOR strategies and programs throughout the products lifecycle, to inform and support clinical development and regulatory needs during early pipeline phase and ensuring optimal market access.

Collaborate with business partners to develop and support compelling product value propositions with aim to optimize patient access.

Identify HEOR evidence requirements and gaps, and design, conduct, and deliver studies and tools to support relative value demonstration and product differentiation.

Leverage RWD analytic tools and collaborate with HEOR RWDnA and Epidemiology teams generating insights to inform development programs and key business questions.

Co-lead conduct of regulatory-grade real world evidence studies and provide education on emerging opportunities for employing RWE across the solid tumor portfolio.

Collaborate on conduct and communication of epidemiology and pharmacoepidemiology analyses and studies.

Provide relevant input into selection of patient population, comparators and endpoints within clinical trials to enable demonstration of robust incremental value over standard of care that can facilitate optimal patient access.

Develop and implement Clinical Outcomes Assessment (COA) measurement strategies and plans in support of product labeling, patient access and product differentiation.

Develop and validate COA endpoints for integration in clinical studies. Produce COA evidence dossiers for regulatory submissions.

Evaluate relevant payer and health technology assessment (HTA) decisions, collect feedback in advisory meetings and apply key takeaways.

Maintain an up-to-date awareness of regulatory and payer/HTA considerations that may impact planning for and implementation of HEOR programs.

Report, publish and disseminate HEOR data and study results in compliance with company, industry and regulatory requirements.

**This role requires:**

An Advanced degree (Ph.D., MS, or MD, PharmD., B.Pharm with Masters degree) in HEOR-related field and 4+ years with PhD or 6+ years with MS in HEOR; at least 3 years of life science company or healthcare consulting experience is a plus.

Strong technical expertise required in design and conduct of HEOR studies and models.

Solid understanding of regulatory (e.g. FDA, EMA) and HTA considerations.

Experience in design and implementation of patient experience data in clinical trials, including experience in instrument selection, analysis and reporting of data.

Experience with Oncology is preferred

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$176,100.00 - $287,300.00

Senior Director, Assistant General Counsel Market Access Legal

**Build Our Future Together**

The Senior Director, Assistant General Counsel Market Access Legal will provide proactive, efficient, strategic, and collaborative legal support to Regenerons Market Access Commercial Business Unit. More specifically, this person will advise a wide range of internal Market Access and other clients, including Market Access Strategy; National and Regional Payer Account Teams; the Government Pricing, Contract Strategy, Pricing, and Operation Team; as well as Commercial; Marketing; Sales; Public Policy and Government Affairs; Regulatory; and Corporate Compliance. The level of counseling requires a deep understanding of market access principles, market access strategy, payers, pharmacy benefit managers (PBM), payer and PBM contracts, pharmaceutical distribution channels, contract operations, government pricing, regulatory and compliance issues, the False Claims Act, the Anti-Kickback Statute, and OIG guidance, and other applicable state and federal healthcare laws.

**When & where:**

- Work Location: Sleepy Hollow, NY
- Work model/flexibility: 4 days per week on site

**Discover your role:**

- Providing proactive, efficient, strategic, and collaborative legal advice and support on market access, market access strategy, payer and PBM contracts, payer and PBM strategies, government pricing, and other Commercial-related matters in a fast-paced environment
- Providing legal guidance on various issues, tactics, and activities, including market access strategy development, creation of market access materials, contract drafting and negotiation, government pricing reporting, and interactions with healthcare providers, distributors, pharmacies, payers, PBMs, and GPOs
- Drafting and negotiating a wide variety of commercial contracts including payer and PBM agreements, GPO agreements, distribution agreements, pharmacy agreements, rebate agreements, service agreements, and other corporate agreements
- Provide support to various Commercial teams and Product Attorneys on product-specific Market Access issues
- Provide support to Corporate Compliance on Market Access issues
- Maintain an independent and objective perspective while developing and maintaining a strong partnership with the client organizations

**This role requires:**

- Juris Doctor degree with 10+ years relevant legal experience
- Licensed to practice law in New York or be eligible for licensure as a registered in-house counsel
- Prior in-house healthcare/pharmaceutical and/or biotech experience required
- Significant knowledge of life sciences regulatory enforcement trends, market access, market access strategy, payer and PBM-related issues, payer and PBM contracts, other market access contracts, contract operations, government pricing requirements (ideally for both medical and pharmacy benefit products), regulatory and compliance issues, the FDCA, the False Claims Act, federal and state fraud and abuse laws, and antitrust laws
- Excellent interpersonal and conflict resolution skills, and ability to work in highly collaborative, team-oriented environment
- Excellent understanding of healthcare laws and proven experience in applying them to complex business situations

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$242,000.00 - $403,300.00

Associate Manager, Regulatory Affairs Strategy - Oncology

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an **Associate** **Manager** to join our **Regulatory Affairs Strategy (Oncology)** team.

The Associate Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

- Work Location: Tarrytown, NY or Warren, NJ
- 4 days per week on site

**Discover your role:**

- Coordinating the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development in oncology therapeutic area, including, but not limited to, the following: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigators Brochure
- Assisting in coordination and preparation for Agency meetings and associated briefing document preparation
- Managing and tracking queries and commitments with regulatory agencies, collaborates with subject matter experts to provide written responses to queries, provides periodic status updates regarding conditions/commitments
- Providing representation for study-level regulatory activities and participate in cross-functional departmental team projects and product development activities/meetings
- Performing research to support the development of regulatory strategy for the assigned clinical development program
- Maintaining knowledge of regulatory requirements up to current date, comments on draft regulatory guidance, and communicates changes in regulatory information as needed
- Exercising discretion and independent judgment in the performance of the duties described above

**This role requires:**

- Minimum MD, PhD or PharmD degree along with relevant internship, fellowship, post-doc experience or industry experience
- Experience in oncology preferred
- Knowledgeable of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
- Experience interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations preferred
- High attention to detail; ability to organize and prioritize assigned projects according to corporate goals
- Ability to work in close collaboration with colleagues in regulatory department and throughout the development organization
- Proficient in written, oral, and interpersonal communications in English

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$109,900.00 - $179,300.00

Manager, Regulatory Affairs, Advertising & Promotion

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a **Manager** to join our **Regulatory Affairs Advertising and Promotion** team. In this role, you will apply clinical development knowledge in concert with experienced understanding of advertising and promotion regulations/guidances to the development of key product messages presented in Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs). This individual will provides regulatory advertising and promotion expertise to relevant stakeholders, typically carrying out the responsibilities with guidance from the Regulatory Affairs, Advertising and Promotion Director. The Manager Regulatory Affairs, Advertising and Promotion will oversee therapeutic area(s) and ensure that messages are translated into advertising and promotion initiatives that meet the commercial teams objectives, while maintaining the necessary state of compliance and corporate integrity.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

- Work Location: Sleepy Hollow, NY or Warren, NJ
- 4 days per week on site

**Discover your role:**

- Management of US regulatory activities associated with advertising and promotion of the companys marketed products. Manages commercial activities from a regulatory advertising and promotion perspective with guidance from the Regulatory Affairs, Advertising & Promotion Director.
- Creatively contribute to the advise on the development of product messages and materials across multiple functional areas.
- Provide timely regulatory advice and guidance, with guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs
- Provide review of US and Global (if applicable) product and disease state materials/communications, with guidance from Regulatory Affairs, Advertising & Promotion Director, to support corporate goals and comply with applicable laws, regulations, and guidance.
- Collaborate cross functionally with key stakeholders in areas such as Marketing, Medical Affairs, and Legal.
- Responsible for establishing working relationship and managing communication with regulatory advertising and promotion professionals at co-promote partner companies
- Help lead and assist in all interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned company products, responsible for helping to maintain working relationship and effective communication with FDA OPDP reviewers with respect to advertising and promotion matters, including request for advisory submissions.
- Responsible for compliance with promotional material submissions to FDA on Form 2253
- Monitor the external environment to advise product teams on evolving regulatory requirements related to product and disease state communications
- Maintain vigilance with respect to FDA promotional enforcement activities; provide stakeholders with updates on a regular basis; in partnership with management, provide guidance to stakeholders with respect to impact of enforcement activities on the company policies.
- Ability to identify process improvement for promotional review activities that would enable the establishment of portfolio wide standardization of policies
- Ability to cross train across products/indications to ensure continuous Regulatory A&P support is provided to stakeholders
- Collaboration with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports
- With guidance from management, help provide input during review cycles to reflect commercialization objectives and messages in the submission documents/reports that are submitted to health authorities
- Provide input to management during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising.

**This role requires:**

- A minimum of 2 total years relevant experience, preferably within Regulatory Advertising and Promotion
- At minimum, a Bachelor's degree (BS) from an accredited college or university in Life Sciences. An Advanced Scientific degree (i.e., Masters, PharmD, Ph.D) is preferred.
- Knowledge of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in the area of advertising and promotion
- Experience with pharmaceutical products required, biologics experience is a plus
- Experience working directly/indirectly with the FDA, specifically OPDP/APLB is preferred
- Ability to review promotional materials and interact with FDA OPDP/APLB and support launch products/campaigns, while maintaining excellent written/verbal communication skill when giving strategic regulatory advice
- Ability to support global promotional review, understanding of clinical trial recruitment materials, and familiarity with labeling regulations is desirable
- Contributes to the influence of cross-functional teams and may interact with senior management

\#GDRAJobs

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$128,600.00 - $210,000.00

Nationwide

Senior Manager, Regulatory Affairs, Advertising & Promotion

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager to join our Regulatory Affairs Advertising and Promotion team. This position requires the ability to apply clinical development knowledge in concert with experienced understanding of advertising and promotion regulations/guidance to the development of key product messages presented in Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs). They will provide regulatory advertising and promotion expertise to relevant stakeholders, typically carrying out the responsibilities with minimal guidance from the Regulatory Affairs, Advertising and Promotion Director. The Senior Manager Regulatory Affairs, Advertising and Promotion will oversee therapeutic area(s) and ensure that messages are translated into advertising and promotion initiatives that meet the commercial teams objectives, while maintaining the necessary state of compliance and corporate integrity.

**When & where:**

- Work Location: Sleepy Hollow, NY or Warren, NJ
- 4 days per week on site

**Discover your role:**

- Management of US and Global (if applicable) regulatory activities associated with advertising and promotion of the companys marketed products, as well as commercial development of pipeline products. Manages commercial activities from a regulatory advertising and promotion perspective with minimal guidance from the Regulatory Affairs, Advertising & Promotion Director.
- Creatively advise on the development of product messages and materials across multiple functional areas.
- Provide timely regulatory advice and guidance, with minimal guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs
- Provide review of US and Global (if applicable) product and disease state materials/communications, with minimal guidance from Regulatory Affairs, Advertising & Promotion Director, to support corporate goals and comply with applicable laws, regulations, and guidance.
- Collaborate cross functionally with key stakeholders in areas such as Marketing, Medical Affairs, and Legal.
- Responsible for establishing working relationship and managing communication with regulatory advertising and promotion professionals at co-promote partner companies
- Help lead and assist in all interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned company products, responsible for helping to maintain working relationship and effective communication with FDA OPDP reviewers with respect to advertising and promotion matters, including request for advisory submissions.
- Responsible for compliance with promotional material submissions to FDA on Form 2253
- Monitor the external environment to advise product teams on evolving regulatory requirements related to product and disease state communications
- Maintain vigilance with respect to FDA promotional enforcement activities; provide stakeholders with updates on a regular basis; provide guidance to stakeholders with respect to impact of enforcement activities on the company policies.
- Provide input to direct management with respect to process improvement for promotional review activities and establishment of portfolio wide standardization of policies
- Ability to cross train across products/indications to ensure continuous Regulatory A&P support is provided to stakeholders
- Collaboration with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports
- With minimal guidance from management, help provide input during review cycles to reflect commercialization objectives and messages in the submission documents/reports that are submitted to health authorities
- Provide input to management during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising.

**This role requires:**

- A minimum of 3 to 4 years within regulatory affairs, preferably within advertising and promotion
- At minimum, a Bachelors degree (BS) from an accredited College or University in Life Sciences. Advanced degree (Masters, Pharm D, Ph.D., MD or DO) preferred in the field of medicine or science. Regulatory experience can offset education requirements.
- Advance knowledge of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in the area of advertising and promotion
- Experience with pharmaceutical products required, biologics experience is a plus
- Experience working directly/indirectly with the FDA, specifically OPDP/APLB is preferred
- Ability to review promotional materials and interact with FDA OPDP/APLB and managing launch products/campaigns, while maintaining excellent written/verbal communication skill when giving strategic regulatory advice
- Ability to support global promotional review, understanding of clinical trial recruitment materials, and familiarity with labeling regulations is desirable
- Ability to influence cross-functional teams and interact with senior management

\#GDRAJobs

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$150,500.00 - $245,500.00

Associate Manager, Regulatory Advertising & Promotion

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an **Associate Manager** to join our **Regulatory Affairs Advertising and Promotion** team.

The Associate Manager position within the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with experienced understanding of advertising and promotion regulations/guidances to the development of key product messages presented in Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs). Provides regulatory advertising and promotion expertise to relevant stakeholders, typically carrying out the responsibilities with guidance from the Regulatory Affairs, Advertising and Promotion Director. The Associate Manager Regulatory Affairs, Advertising and Promotion will oversee therapeutic area(s) and ensure that messages are translated into advertising and promotion initiatives that meet the commercial teams objectives, while maintaining the necessary state of compliance and corporate integrity.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

- Work Location: Sleepy Hollow, NY or Warren, NJ
- 4 days per week on site

**Discover your role:**

- Contribute to the management of US regulatory activities associated with advertising and promotion of the companys marketed products. Manages commercial activities from a regulatory advertising and promotion perspective with guidance from the Regulatory Affairs, Advertising & Promotion Director.
- Contribute to the advise on the development of product messages and materials across multiple functional areas.
- Assist with providing timely regulatory advice and guidance, with guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs
- Assist with providing review of US and Global (if applicable) product and disease state materials/communications, with guidance from Regulatory Affairs, Advertising & Promotion Director, to support corporate goals and comply with applicable laws, regulations, and guidance.
- Ability to collaborate cross functionally with key stakeholders in areas such as Marketing, Medical Affairs, and Legal.
- Contributes to the working relationship and managing communication with regulatory advertising and promotion professionals at co-promote partner companies
- Assist with interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned company products, assist with helping to maintain working relationship and effective communication with FDA OPDP reviewers with respect to advertising and promotion matters, including request for advisory submissions.
- Responsible for compliance with promotional material submissions to FDA on Form 2253
- Monitor the external environment to advise product teams on evolving regulatory requirements related to product and disease state communications
- Maintain vigilance with respect to FDA promotional enforcement activities; provide stakeholders with updates on a regular basis; help assess the potential impact of enforcement activities on the company policies.
- Knowledge of process improvement for promotional review activities that would enable the establishment of portfolio wide standardization of policies
- Knowledge of products/indications to help provide continuous Regulatory A&P support is provided to stakeholders
- Collaboration with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports
- Knowledge of the input provided during review cycles to reflect commercialization objectives and messages in the submission documents/reports that are submitted to health authorities
- Ability to understand and work with management during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising.

**This role requires:**

- A minimum of 1 to 2 years within regulatory affairs, preferably within advertising and promotion or completion of a Post-Doctoral Fellowship Program with related experience focused on Regulatory Affairs, including Advertising and Promotion
- Requires advanced scientific degree (i.e., Masters, PharmD, Ph.D) or at minimum, a Bachelor's degree (BS) from an accredited college or university in Life Sciences.
- Fundamental understanding of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in the area of advertising and promotion
- Experience with pharmaceutical products is highly preferred, biologics experience is a plus
- Experience working directly/indirectly with the FDA, specifically OPDP/APLB is desirable
- Ability to review promotional materials and interact with FDA OPDP/APLB and help support launch products/campaigns, while maintaining excellent written/verbal communication skill
- Familiarity with global promotional review, clinical trial recruitment materials, and labeling regulations is desirable
- Contributes to the influence of cross-functional teams and may interact with senior management

\#GDRAJobs

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$109,900.00 - $179,300.00

Senior Developer - Research and Development

**Build our future together:**

Regeneron is seeking an outstanding Senior Developer to design, develop, and deliver informatics solutions that enable our research and preclinical development pipeline. This role focuses on LIMS/ELN platform development, scientific data integrations, and building AI-powered capabilities that accelerate scientific workflows. The ideal candidate brings a data-first perspective approaching every problem by understanding the underlying data, its structure, and how it flows across systems before writing code. You will serve as a technical lead driving architecture decisions, mentoring team members, and delivering high-quality solutions on COTS platforms including Sapio, Benchling, and Dotmatics.

**Where:** Based at our Tarrytown, NY location

**Where:** 4 days onsite per week required

**Discover your role:**

- Own the design and development of server-side plugins, integrations, and workflows on LIMS/ELN platforms (Sapio preferred) using Java and Python
- Architect and build AI/GenAI-enabled solutions (LLM agents, RAG pipelines, prompt-engineered workflows) to streamline R&pD informatics processes
- Develop data pipelines and integrations between scientific instruments, LIMS/ELN systems, and enterprise data platforms owning data modeling, transformation logic, and data quality validation end-to-end
- Serve as technical lead on projects defining technical approach, conducting code reviews, and mentoring developers
- Partner with scientists, lab operations, and product owners to translate scientific requirements into scalable technical solutions
- Evaluate and implement COTS platform capabilities (Sapio, Benchling, Dotmatics) to enhance out-of-the-box functionality before custom development
- Design and develop REST APIs, webhooks, and middleware to enable interoperability across R&PD systems
- Apply a data-first approach to problem-solving analyze scientific datasets, identify data quality issues, build dashboards and reporting solutions, and translate data insights into actionable recommendations for scientific collaborators
- Contribute to platform modernization initiatives, including cloud migration and containerized deployments
- Ensure solutions meet GxP compliance requirements where applicable

**This role requires:**

- Bachelor's degree in Computer Science, Bioinformatics, Life Sciences, or related field
- 2+ years of work experience in software development supporting life sciences R&D or laboratory informatics
- Proficiency in Java (server-side development, plugin architectures)
- Proficiency in Python (scripting, data pipelines, webhooks, automation)
- Experience with at least one LIMS or ELN platform: Sapio, Benchling, or Dotmatics. Experience with Sapio LIMS/ELN (server-side plugins, workflows, data model configuration) is preferred.
- Proven experience with AI/GenAI technologies: building LLM-powered agents, prompt engineering, retrieval-augmented generation (RAG), or AI-assisted workflow automation. Experience with AI agent frameworks (LangChain, LlamaIndex, Claude/Anthropic APIs, OpenAI APIs) is preferred.
- Familiarity with containerization (Docker, Kubernetes) and CI/CD pipelines (Jenkins, GitHub Actions) is a plus
- Experience with instrument integrations (TetraScience or direct instrument interfaces) is preferred
- Experience with data analytics and visualization tools (Spotfire, Tableau, Power BI, or Jupyter notebooks) to support data-driven decision-making is a plus

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$93,900.00 - $153,300.00

Senior Manager, Regulatory Affairs

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager Regulatory Strategy Oncology & Japan Affairs to join our Regulatory Affairs team, supporting our Japan business in a hybrid work model. In this role, you will lead Japan regulatory strategies across multiple therapeutic areas while collaborating with global regulatory teams and local cross-functional partners. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

Location: Japan

Work model: Hybrid

**Discover your role:**

Plan and execute Japan regulatory strategies and PMDA consultations for assigned programs

Lead marketing application and post-approval change submissions

Partner with local and global leadership to support Regulatory Affairs operations

Manage interactions with PMDA and other Japanese health authorities

Lead or support clinical trial notification preparation and submission activities

Represent Regulatory Affairs within clinical, commercial, medical, and patient safety teams

Support local labeling, patient information, and promotional material review activities

You build strong partnerships across a global matrix environment

**This role requires:**

Bachelor's degree in a scientific discipline; Master's degree preferred

10+ years in the pharmaceutical industry and 5+ years of relevant regulatory experience

Experience managing health authority interactions, major submissions, and approvals in Japan

Deep knowledge of Japan submission requirements, local regulations, and regulatory standards

Knowledge of clinical trial requirements and ability to resolve local procedural challenges

Experience supporting business start-up activities

Ability to ensure compliance with Japan regulatory requirements and local standards

Strategic thinking, commercial awareness, and strong written and verbal communication skills

Ability to thrive in and foster effective matrix teamwork in a global environment

Fluent Japanese and English language skills

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.