Regulatory Strategist

Sanofi•Cambridge, MA

70d

About The Position

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. Our team is involved in developing regulatory product strategies for the Immunology and Inflammation therapeutic area, leading regulatory efforts in the development stage of drug products. 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. 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
Emerging business acumen, leadership, influencing and negotiation skills
Ability to use appropriate interpersonal styles and techniques to build internal and external networks and lead discussions with internal and external stakeholders.
Effective communication skills, specifically strong oral and written presentation skills.
Experience working in and strong knowledge of electronic document management systems (e.g. Veeva Vault RIM, Plai).
Demonstrated ability to manage multiple projects/deliverables simultaneously.
Strong sensitivity for a multicultural/multinational environment

Responsibilities

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, One Sanofi regulatory voice through participation in appropriate committees, forums at the direction of the GRL
Proactively contribute with curiosity and openness to diverse perspectives
Emerging understanding of clinical development of drugs and/or novel biologics products
Understanding of business acumen, leadership, influencing and negotiation skills
Contribute to operational and compliance activities for assigned deliverables, develop, execute and maintain including generating submission content plans, submission tracking, and document management utilizing the support and input of cross-functional team and/or alliance partners where relevant
Effective communication skills, specifically strong oral and written presentation skills preferred
Ability to work in electronic document management systems (e.g. Veeva vault, Plai) is a plus
Demonstrated ability to handle multiple projects/deliverables simultaneously is preferred
Strong sensitivity for a multicultural/multinational environment.

Benefits

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 and at least 14 weeks' gender-neutral parental leave.

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