Regulatory Affairs CMC Manager, Europe CMC Lead
Core
Lead CMC regulatory activities from planning through delivery for complex client programs in the EU, acting as a trusted regulatory partner and client-facing contact.
Role type
Senior Regulatory Affairs Manager (CMC Lead)
Builds
Regulatory dossiers (CTD/Module 3) and responses to Health Authority questions for pharmaceutical products.
Domain
Life Sciences / Pharmaceuticals / Regulatory Affairs
Required skills
EU CMC regulatory requirements, MAA dossier structures, CTD/Module 3, pharmaceutical manufacturing controls, project management, risk management, cross-functional team leadership, client-facing communication
Preferred skills
Proposal support, RFPs, bid defenses, Veeva Regulatory Vault experience
Technologies
Veeva Regulatory Vault
Responsibilities
Lead planning and delivery of complex CMC regulatory activities; Provide regulatory CMC guidance on dossier requirements and Health Authority expectations; Review CMC documentation from development and manufacturing teams; Coordinate CMC deliverables, timelines, and responses to Health Authority questions; Lead cross-functional teams in a matrix environment; Act as key client-facing Regulatory CMC contact; Support RFPs, proposals, and bid defenses; Provide guidance to less-experienced team members.
Seniority
Senior, hands-on IC with mentorship responsibilities