Regulatory Strategist at Sanofi, candidates with an advanced Life Sciences degree- Apply Now
Are you a strategic and experienced Regulatory Affairs professional with a Bachelor’s degree in a relevant field and at least 6 years in the pharmaceutical/biotechnology industry? Sanofi, an innovative global healthcare company, is seeking a talented Regulatory Strategist to join our Global Regulatory Team in either Cambridge, MA or Morristown, NJ, USA. If you are ready to shape the future of medicine by defining and executing global regulatory strategies, we encourage you to apply!
About the Company:
Sanofi is an innovative global healthcare company dedicated to advancing the miracles of science to enhance peopleโs lives. We provide opportunities for career growth and development, fostering a collaborative environment where individuals can push boundaries and make meaningful connections.
Job Details
- Job Title: Regulatory Strategist
- Location: Cambridge, MA/Morristown, NJ
- Time Type: Full-time
- Posted on: Posted 5 Days Ago
- End Date to Apply: July 18, 2025 (30+ days left to apply)
- Job Requisition ID: R2796718
About the Job
Are you ready to shape the future of medicine? Join our Global Regulatory Team as a Regulatory Strategist to accelerate drug discovery and development. Your expertise will play a crucial role in defining and executing global regulatory strategies, facilitating Health Authority interactions, and supporting business objectives.
Main Responsibilities
As a Regulatory Strategist at Sanofi, your main responsibilities will include:
- Providing regulatory input and guidance to internal project teams.
- Contributing to the development and execution of global regulatory strategies for pharmaceutical products.
- Leading interactions with Health Authorities and preparing regulatory submission documents.
- Supporting operational and compliance activities related to regulatory filings and approvals.
About You
Qualifications:
- 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.
- At least 6 years of relevant pharmaceutical/biotechnology experience, including at least 4 years of relevant Regulatory Affairs experience (regional and global), in early and late stage, development of multiple modalities; experience within regulatory CMC not directly applicable.
- Demonstrated experience with preparation of (s)BLA/(s)NDA/MAA, INDs/CTAs, HA meeting briefing documents and negotiating with a national/regional HA preferred.
- Experience on multidisciplinary matrixed project teams (e.g. clinical study team) preferred.
- Project leadership experience preferred.
Why Choose Us?
- Collaborate with a future-focused team
- Grow your career with diverse opportunities
- Enjoy comprehensive benefits and rewards
Apply now to be part of our mission to make miracles happen!
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