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Biologics CMC Regulatory Lead — Senior Director; Hybrid
Job in
Boston, Suffolk County, Massachusetts, 02298, USA
Listed on 2026-07-29
Listing for:
BioSpace
Full Time
position Listed on 2026-07-29
Job specializations:
-
Pharmaceutical
Regulatory Compliance Specialist -
Management
Regulatory Compliance Specialist
Job Description & How to Apply Below
Beeline Medicines seeks a Senior Director, Regulatory Affairs CMC – Biologics to lead regulatory science for biologics assets, including monoclonal antibodies, from IND/CTA through BLA and post‑approval lifecycle. You will collaborate with Process Development, Analytical Sciences, Quality, and external CMOs to align with FDA/EMA expectations and global health authority standards.
The role requires deep CMC regulatory expertise, strategic vision, and leadership to shape the regulatory
#J-18808-LjbffrPosition Requirements
10+ Years
work experience
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