Regulatory Strategist – Sanofi

Regulatory Strategist jobs at Sanofi are open right now for candidates who want to shape global drug development strategy at one of the world’s leading R&D-driven biopharma companies. This particular opening sits within Sanofi’s Global Regulatory Team (GRT) and is based in Morristown, New Jersey or Cambridge, Massachusetts, with a disclosed salary range of $148,500–$214,500 USD per year.

Quick Facts

1. Job Title: Regulatory Strategist
2. Company: Sanofi
3. Locations: Morristown, NJ / Cambridge, MA (hybrid/onsite per team)
4. Department: Research and Development – Regulatory Affairs
5. Salary Range (Sanofi-disclosed): $148,500 – $214,500 / year
6. Req ID: R2859333 · Listing ID: 40300121600
7. Apply by: Rolling / Open until filled (confirm on employer site).

Role Profile

1. Providing regulatory input to clinical development, commercial, and cross-functional GRT partners.
2. Contributing to the Target Product Profile (TPP), governance, and business planning as part of “one regulatory voice”.
3. Developing the Global Regulatory Project Strategy (GRPS) and aligning it with core product labeling.
4. Owning Health Authority engagement plans, including authoring briefing documents and leading HA meetings.
5. Leading submission teams to ensure NDA/BLA/MAA/Extension filings hit launch timelines.
6. Directing IND/CTA submission strategy to keep clinical trial initiation on schedule.
7. Managing submission content planning, tracking, and document management with cross-functional and alliance partners.

Also check: Senior Biotechnologist – Sanofi

Qualifications and Requirements

1. A BS/BA in a relevant scientific discipline (advanced degree — PharmD, PhD, MD, DVM, or MSc — preferred).
2. 6+ years in pharma/biotech, including 4+ years in Regulatory Affairs (regional and global).
3. Experience preparing (s)BLA/(s)NDA/MAA and IND/CTA filings, plus HA briefing documents.
4. Prior work on multidisciplinary, matrixed project teams.
5. Project leadership experience is a plus.