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Senior Director, Biologics CMC Regulatory Strategy
Job in
Boston, Suffolk County, Massachusetts, 02298, USA
Listed on 2026-07-27
Listing for:
Doist
Full Time
position Listed on 2026-07-27
Job specializations:
-
Pharmaceutical
Regulatory Compliance Specialist
Job Description & How to Apply Below
Beeline Medicines is seeking a Senior Director, Regulatory Affairs CMC – Biologics to lead regulatory science for biologics assets across the development lifecycle. You will drive global CMC strategy, author submissions, and coordinate with Process Development, Analytical, and Quality to ensure robust, inspection‑ready programs.
You will communicate with Health Authorities, advise on ICH guidelines for large molecules, and shape post‑approval change management and lifecycle strategies in a
#J-18808-LjbffrPosition Requirements
10+ Years
work experience
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