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CMC Regulatory Lead, Biologics; Phase - Hybrid Boston
Job in
Boston, Suffolk County, Massachusetts, 02298, USA
Listed on 2026-02-06
Listing for:
Vivid Resourcing
Full Time
position Listed on 2026-02-06
Job specializations:
-
Management
Healthcare Management -
Healthcare
Healthcare Management
Job Description & How to Apply Below
A clinical-stage biotech firm is seeking a Director/Senior Director of Regulatory Affairs, CMC to lead the regulatory strategy for a pivotal Phase 3 biologic therapy. This high-impact role requires 10+ years of Regulatory Affairs experience and proven success with late-stage submissions. Responsibilities include defining the CMC regulatory strategy, preparing IND and BLA submissions, and engaging with global regulatory agencies. Candidates should possess strong collaborative communication skills and a deep understanding of biologics manufacturing.
This position offers hybrid work flexibility and significant autonomy in a science-driven environment.
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