Director, CMC Management
Core
Lead CMC regulatory strategy, submissions, and external CDMO support for a biologics pipeline.
Role type
Director, CMC Management
Builds
Regulatory filings and clinical product supply for biologics
Domain
Biologics / Pharmaceutical Manufacturing
Required skills
CMC regulatory strategy, regulatory submissions, CDMO management, drug substance and drug product development, manufacturing compliance
Responsibilities
Prepare CMC regulatory filings, provide technical guidance to CDMO on drug substance and drug product development and manufacturing, ensure CMC compliance with all applicable regulations, partner with Quality, Portfolio management, and Regulatory Affairs teams to ensure timely delivery of CMC regulatory sections and timely supply of clinical products
Seniority
Director, strategic leadership & cross-functional coordination