Regulatory Strategist at Sanofi – Lifescience Candidates Apply Now!
Sanofi is seeking an experienced Regulatory Strategist to help drive the future of medicine. If you have a background in Regulatory Affairs and want to contribute to groundbreaking drug discovery and development, this is your opportunity. Join a global leader in pharmaceuticals and play a vital role in shaping regulatory strategies. Apply now!
Job Details:
- Job Title: Regulatory Strategist
- Location: Cambridge, MA (Hybrid)/ Bridgewater, NJ (Hybrid)
- End Date: June 26, 2025
- Job Requisition ID: R2788818
Main Responsibilities:
- Provide regulatory expertise and guidance on procedural and documentation requirements
- Collaborate with internal teams to ensure successful regulatory outcomes
- Contribute to the development of regulatory strategies
- Manage operational and compliance activities for assigned deliverables
- Utilize strong communication skills to drive effective regulatory processes
Education:
- BS/BA degree in a relevant scientific discipline required. Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) preferred
Experience:
- At least 8 years of prior pharmaceutical/biotechnology industry experience, including at least 6 years of relevant Regulatory Affairs experience (regionally and/or global) especially in development phase
- Demonstrated experience with preparation of (s)BLA/(s)NDA/ MAA, INDs/CTAs, Health Authority meeting briefing documents and negotiating with a national/regional Health Authority preferred. Experience on multidisciplinary matrixed project teams (e.g. clinical study team)
- Project leadership experience preferred
Soft Skills:
- Proactively contribute with curiosity and openness to diverse perspectives
- Advanced understanding of clinical development of drugs and/or innovative biologics products
- Demonstrated significant leadership 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
- Demonstrates business acumen, leadership, influencing and negotiation skills
- Demonstrated ability to use appropriate interpersonal styles and techniques to build internal networks and lead negotiations with internal and external stakeholders
- Highly effective communication skills, specifically strong oral and written presentation skills
- Excellent time-management and operational skills including planning and organizing
- Demonstrated experience working in and strong knowledge of electronic document management systems to obtain and leverage regulatory deliverables (e.g. Veeva vault, Plai)
- Demonstrated ability to handle multiple complex projects/deliverables simultaneously
- Self-motivated and able to work in a highly matrixed structure including sharing knowledge with relevant stakeholders
- Understanding of the therapeutic area marketplace and drug development
- Strong sensitivity for a multicultural/multinational environment
Why Choose Us?
Join our supportive, future-focused team to bring the miracles of science to life. Explore endless opportunities for career growth and enjoy a comprehensive rewards package designed to amplify your impact.
Keywords: Regulatory Strategist, Sanofi, Drug Discovery, Regulatory Affairs, Pharmaceutical Industry, Scientific Discipline
