Regulatory Strategist

Sanofi•Cambridge, MA

1d•Onsite

About The Position

Our team is involved in developing regulatory product strategies for the oncology therapeutic area, leading regulatory efforts in the development stage of drug products. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? 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 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. Together, we chase the miracles of science to improve people’s lives.

Requirements

BS/BA degree in a scientific discipline required (e.g. Biology, Life Science, or related field); OR Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field).
BS/BA degree in a scientific discipline or MSc in Biology, Life Science, or related field with at least 6 years of relevant pharmaceutical/biotechnology industry experience, including at least 6 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 is preferred.
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 is desirable.
Experience working in and strong knowledge of electronic document management systems (e.g. Veeva Vault RIM, Plai) is desirable
Effective communication skills, specifically strong oral and written presentation skills.
Sensitivity for a multicultural/multinational environment
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.
Demonstrated ability to manage multiple projects/deliverables simultaneously.

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.
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.
Help improve the lives of millions of people globally by making drug development quicker and more effective.
Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

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