Regulatory Affairs CMC Senior Specialist – EU CMC Lead
Core
Coordinate CMC regulatory dossiers and responses to Health Authority questions across multiple countries for pharmaceutical products.
Role type
Senior Regulatory Affairs CMC Specialist (EU CMC Lead)
Builds
Regulatory documentation and responses for Health Authorities
Domain
Life Sciences / Pharmaceuticals / Regulatory Affairs
Required skills
Project coordination, Stakeholder management, CMC regulatory requirements knowledge, NDA/MAA dossier structures, CTD format, Pharmaceutical manufacturing principles, Document review, Risk identification, Global team collaboration
Preferred skills
Veeva Regulatory Vault experience
Responsibilities
Coordinate CMC regulatory dossier activities and responses to Health Authority questions, Track deliverables and timelines, Lead tracking meetings, Manage document review and approval processes, Review CMC documentation from a regulatory perspective, Proactively identify and escalate risks
Seniority
Senior, hands-on IC