Regulatory Strategist

About this role

Job title : Regulatory Strategist • Location: Morristown, NJ

About the job

The Polio, Pertussis and Haemophilus influenzae type b (Hib) or PPH franchise is dedicated to safeguarding health through vaccines that protect against Polio, Pertussis, Tetanus, Hib, Diphtheria, and Hepatitis B.

The RA PPH team is responsible for developing and executing strategic regulatory initiatives that maintain market leadership, support continuous product improvements, and ensure sustained compliance with evolving global regulations. The team serves as the critical interface between R&D, manufacturing, and Health Authorities to navigate regulatory requirements, manage lifecycle strategies, and drive market access for the PPH vaccine portfolio

This position requires agility to work transversally across the PPH Franchise and the broader Vaccines Global Business Unit (GBU), with a primary focus on PPH combination vaccines across Canadian and French products, and flexibility to support other Therapeutic Areas within the GBU as needed. The scope of the licensing work will include both established product licensing and Research and Development.

As a key member of the GRT, and strategic partner to the GRL, the Regulatory Strategist (RS) leverages their regulatory expertise to contribute to the definition of the global regulatory strategy, to enable and drive the execution of aligned US, EU and/or global regulatory strategy for assigned projects, including Health Authority interactions.

The Regulatory strategist provides regulatory expertise and guidance on procedural and documentation requirements to GRT and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s 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 people’s lives.

Main Responsibilities:

• The RS enables the GRL by providing quality regulatory input and position to internal business partners, including but not limited to the clinical development teams, commercial and Global Regulatory Team for assigned projects.

• Liaises with clinical, commercial, and other internal business partners in partnership with the GRL to enable successful regulatory outcomes.

•  Contributes to the development of a harmonized, regulatory voice through participation in appropriate committees, forums at the direction of the GRL

• Contributes to the Global Regulatory Team (GRT) for assigned projects in alignment with the team’s one regulatory voice for providing strategic input on the  governance committees.

• May represent GRT strategic position on behalf of the GRL at regulatory forums/committees at request of GRL.

• May serve as a regional/local regulatory lead and point of contact with Health Authorities for projects/products in their remit, as needed.

• Identifies regulatory risks and proposes mitigations in collaboration with the GRL, to cross-functional teams working with Sanofi standardized methodologies as appropriate.

• The RS contributes to the development of Global Regulatory Project Strategy and ensures alignment with the core product labeling for vaccines in his/her remit.

• Ensure that respective regulatory team members have the information necessary to contribute to the development and execution of the Global Regulatory Strategy for their responsible accountabilities.

• Leads submission team or regulatory sub team to ensure NDA/BLA/ MAA/Extensions filings meet the project timelines for product launch and is responsible for the development and update of the core global dossier / collaborates with regional lead where region-specific submissions are applicable.

• Leads the IND/ CTA submission strategy to ensure preparation timelines meet the project timelines for clinical trial initiation

• Contributes to content and reviews regulated documents (such as IB, PBRER, DSUR, RMP, etc).

• Accountable for developing the Health Authority engagement and interaction plans for their assigned products, including the authoring of the briefing document focused on the strategy and scientific content, leading the team through meeting preparations and moderating the meeting itself. The RS attends and may lead Health Authorities meetings as designated

• Supports operational and compliance activities for assigned deliverables, develops, executes regulatory submission planning activities, including generating submission content plans, submission tracking, and document management.

• Accountable for complete and accurate communication/interaction (including tracking) with the relevant HAs for the projects/products in their remit.

About you

Education & Experience • Bachelor’s degree in a relevant scientific discipline or MSc in Biology, Life Science, or related field with at least 5 years of relevant pharmaceutical/biotechnology industry experience, including at least 3 years of relevant Regulatory Affairs experience OR

• Advanced degree (PharmD, PhD, MD or DVM) with at least 2 years of regulatory or relevant pharmaceutical/biotechnology industry experience required.

Technical & Soft Skills • Emerging understanding of clinical development of drugs and/or novel biologics products. Vaccines is a plus.

• Ability to work in electronic document management systems, e.g., Veeva vault is a plus.

• Demonstrated ability to handle multiple projects/deliverables simultaneously is preferred.

• Proactively contribut

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