Regulatory Strategist

Job Title : Regulatory Strategist

Location

Cambridge MA / Morristown, NJ

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

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.

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?

Main 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.

About You

Experience

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

Soft 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

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

Why Choose Us?

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.

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.