US Regulatory Strategist

Sanofi•Morristown, NJ

2d•Onsite

About The Position

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.

Requirements

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.
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).
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

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.