Regulatory Strategist

Job Title

Regulatory Strategist

Morristown, NJ / Cambridge, MA

As a Regulatory Strategist within the R&D team, you will shape the future of medicine by defining and executing global regulatory strategies for assigned projects. You will partner with cross‑functional teams across regions to ensure alignment with US, EU, and global regulatory requirements, lead Health Authority (HA) interactions, and support submissions such as NDA/BLA/MAA, IND/CTA, and regional filings.

• Provide quality regulatory input to the Global Regulatory Team and other business partners.
• Contribute to the Global Regulatory Project Strategy and ensure alignment with core product labeling and lifecycle management.
• Serve as regional/local regulatory lead and point of contact with HAs for assigned products, developing engagement plans and briefing documents.
• Lead HA meetings and preparations, including moderation of meetings.
• Lead submission teams or regulatory sub‑teams to ensure NDA/BLA/MAA, IND/CTA, and extensions filings meet project timelines.
• Create and update global dossiers, collaborate with regional leads for region‑specific submissions.
• Develop and execute regulatory submission planning activities, including content plans, tracking, and document management.
• Support operational and compliance activities for assigned deliverables.

• Minimum BS/BA degree in a relevant scientific discipline.
• Advanced degree (PharmD, PhD, MD, DVM, MSc in Biology or Life Sciences) preferred.
• At least 6 years of pharmaceutical/biotechnology experience, including at least 4 years of regulatory affairs experience (regional and global).
• Experience with early and late‑stage development of multiple modalities; regulatory CMC experience not required.
• Demonstrated experience with preparation of (s)
  BLA/(s)
  NDA/MAA, IND/CTAs, HA meeting briefing documents and negotiation with national/regional HAs.
• Experience on multidisciplinary matrixed project teams and project leadership preferred.

• Competitive salary range: $148,500 – $214,500.
• Full‑time benefits: health, wellness, and parental leave (at least 14 weeks gender‑neutral).
• Opportunities for career growth and international experience.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and affirmative action employers. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, sex, gender, sexual orientation, disability, veteran or military status, or any other characteristic protected by law.