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CMC Regulatory Affairs Executive Leader (Global
Job in
Waltham, Middlesex County, Massachusetts, 02254, USA
Listed on 2026-08-04
Listing for:
Crescent Biopharma
Full Time
position Listed on 2026-08-04
Job specializations:
-
Management
Regulatory Compliance Specialist
Job Description & How to Apply Below
Crescent Biopharma is seeking a senior Regulatory Affairs CMC leader to oversee global submissions and ensure compliance across the product lifecycle. You will lead IND/MAA programs, negotiate with FDA/EMA, and guide Tech Ops and Quality to readiness for clinical and commercial supply.
The role requires 12+ years in CMC regulatory affairs, strong negotiation skills, and experience with biologics/ADC platforms. Leadership and strategic thinking are essential in a fast-paced environment.
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