Manager, CMC Documentation
Core
Authoring and coordinating CMC sections of regulatory submissions (INDs, CTAs, NDAs, BLAs) for small molecules, biologics, and antibody-drug conjugates.
Role type
Manager, CMC Documentation & Specifications
Builds
Regulatory submissions for global health authorities
Domain
Biopharmaceuticals / Regulatory Affairs
Required skills
CMC regulatory documentation, specification authoring, Health Authority inquiry response, data verification, cross-functional collaboration, scientific writing
Preferred skills
Computer-assisted document preparation tools
Responsibilities
Authoring CMC regulatory documents, Leading specification activities for small molecules, Coordinating responses to Health Authority inquiries, Verifying data with attention to detail, Proactively identifying concerns, Collaborating across the organisation
Seniority
Manager, hands-on IC