Manager CMC Regulatory Affairs
Core
Lead regulatory strategy and compliance for biologics CMC (Chemistry, Manufacturing, and Controls) across development, submissions, and post-market programs.
Role type
Manager, CMC Regulatory Affairs (Biologics)
Builds
Regulatory submissions (CTA/INDs, marketing authorizations) and post-approval filings for biologics portfolio
Domain
Biopharmaceuticals / Biologics / Regulatory Affairs
Required skills
CMC regulatory strategy, global regulatory compliance, IND/CTA/post-approval submission experience, SOP development, regulatory authority interaction, change management
Preferred skills
Biologic product experience, FDA interaction experience
Technologies
Regulatory guidelines, SOPs, Reviewer's Guides
Responsibilities
Lead CMC regulatory strategies, assess changes for regulatory impact, review filings for compliance, support regulatory authority interactions, develop Working Instructions and SOPs, identify process gaps
Seniority
Manager, hands-on IC