About this role
Associate Director, Regulatory CMC, Biologics
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locations
Boston, MA
time type
Full time
posted on
Posted Yesterday
job requisition id
REQ-29646
Job Description
General Summary:
The Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across investigational and commercial products focusing on biologics. This role is accountable for authoring, reviewing, and delivering high-quality regulatory submissions, while serving as the primary CMC interface with Health Authorities. The role integrates advanced digital and AI-enabled approaches to enhance the quality, consistency, and efficiency of regulatory document preparation and review.
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