Manager, CMC Regulatory Affairs - Biologics
Core
Lead regulatory strategy and compliance for biologics products across development, submissions, and post-market programs.
Role type
Manager, CMC Regulatory Affairs (Biologics)
Builds
Marketing authorizations, CTA/INDs, and post-approval submissions for biologics
Domain
Biopharmaceuticals / Biologics
Required skills
CMC regulatory strategy, global regulatory compliance, regulatory filing review, regulatory authority interaction, SOP development, process gap analysis
Preferred skills
Biologic product experience, FDA or other regulatory authority engagement
Technologies
CMC, IND, CTA, Marketing Authorization
Responsibilities
Lead CMC regulatory strategies for assigned biologic products; Support CMC development through early phase, submission, and post-market activities; Assess changes and deviations for regulatory impact; Review regulatory filings for compliance; Support regulatory authority interactions; Develop Working Instructions, SOPs, and Reviewer's Guides
Seniority
Manager, hands-on IC