International CMC Regulatory Affairs Manager I
Core
Manage the production of Chemistry, Manufacturing and Control (CMC) documentation and project manage international regulatory submissions for synthetics and biologics.
Role type
Individual Contributor Regulatory Affairs Manager (CMC)
Builds
Regulatory submissions for medicinal products
Domain
Biopharmaceuticals / Regulatory Affairs
Required skills
CMC documentation authoring, international regulatory submission project management, regional regulatory requirements expertise, GxP principles application, risk management, regulatory intelligence, business process optimization
Preferred skills
Drug development process knowledge, regulatory CMC submission experience, Lean capabilities
Technologies
Regulatory submission systems
Responsibilities
Manage timely preparation and delivery of CMC contributions to regulatory submissions; Ensure application of international CMC regulations and lead development of new guidance; Document maintenance and communication of Health Authority approval status; Participate in regulatory execution meetings and provide updates; Contribute to business process optimization activities
Seniority
Senior, hands-on IC