US Regulatory Strategist

Job title: US Regulatory Strategist

• Location: Morristown, NJ

About the Job

As US Regulatory Strategist in the Innovation Franchise Therapeutic Area-General Medicines GBU within our R&D team, you will serve as a key member of the Global Regulatory Team (GRT) and strategic partner to the Global Regulatory Lead (GRL). You will leverage your regulatory expertise to contribute to the definition of the global regulatory strategy and drive the execution of aligned US or global regulatory strategies for projects under development, including Health Authority interactions. In this role, you will provide regulatory expertise and guidance on procedural and documentation requirements to cross-functional teams, contribute to the development of a harmonized, One Sanofi regulatory voice, and identify regulatory risks and propose mitigations.

You will be accountable for developing Health Authority engagement and interaction plans for assigned products, leading submission teams to ensure NDA/BLA/MAA/Extensions filings meet project timelines, and ensuring complete and accurate communication with relevant Health Authorities. You may serve as a regional/local regulatory lead and point of contact with Health Authorities for assigned projects/products, leading meetings and preparations as designated. This position requires strong leadership, strategic thinking, and the ability to navigate complex regulatory environments while maintaining alignment with company 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. Together, we chase the miracles of science to improve people’s lives.

Main Responsibilities

• As a key member of the GRT, and strategic partner to the GRL, the RS leverages their regulatory expertise to contribute to the definition of the global regulatory strategy, to enable and drive the execution of aligned US, or global regulatory strategy for under development projects, including Health Authority interactions.
• May serve as a regional/local regulatory lead and point of contact with Health Authorities for projects/products under development 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
• May lead Health Authority meetings and preparations as designated
• 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.

About You

Qualifications:

• BS/BA 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 skills:

• Understanding of clinical development of drugs and/or innovative biologics products Demonstrated experience with driving the preparation of regulatory documents (e.g. (s)BLA/(s)NDA/ MAA, INDs/CTAs, Health Authority meeting briefing documents) and negotiating with a national/regional Health Authority Experience working in and strong knowledge of electronic document management systems (e.g. Veeva Vault RIM, Plai).

Soft skills:

• Emerging business acumen, leadership, influencing and negotiation skills Effective communication skills, specifically strong oral and written presentation skills Ability to use appropriate interpersonal styles and techniques to build internal and external networks and lead discussions with internal and external stakeholders. Demonstrated ability to manage multiple projects/deliverables simultaneously. Strong sensitivity for a multicultural/multinational environment

Why Choose Us

• Bring the miracles of science to life alongside a supportive, futurefocused 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 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 drugdevelopment quicker and more effective.

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.

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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.