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Regulatory AffairsPharmaceuticalsSenior
Senior Regulatory Affairs Manager
Boston, MAPermanent$150,000 – $185,000Posted 2 weeks ago
About the role
Lead global regulatory strategy for a growing small-molecule portfolio, owning FDA and EMA submissions from IND through approval.
What you’ll do
- Own regulatory strategy across the product lifecycle for assigned programs.
- Author and manage INDs, NDAs, and MAAs in partnership with cross-functional teams.
- Serve as primary liaison with FDA and EMA on submission and review matters.
- Mentor associate regulatory staff and review submission-ready documents.
What you’ll bring
- 8+ years of regulatory affairs experience in pharma or biotech.
- Direct experience leading FDA and/or EMA submissions.
- Strong knowledge of ICH guidelines and the CTD structure.
- RAC certification preferred; advanced scientific degree a plus.
Bektin is an equal-opportunity partner. We present every qualified candidate on merit and keep your details confidential until you approve a submission.