Manager Regulatory CMC Sciences (Injectables)
Core
Develop and implement global CMC regulatory strategies for injectable products, managing lifecycle submissions and ensuring compliance with health authorities.
Role type
Manager, Regulatory CMC Sciences (Injectables)
Builds
Global regulatory submissions and lifecycle management for injectable pharmaceutical products.
Domain
Pharmaceuticals / Regulatory Affairs / CMC
Required skills
Global CMC regulatory strategy, injectable/parenteral product submissions, US FDA regulations, cGMP/CFR/USP/Ph. Eur. knowledge, regulatory documentation authoring, cross-functional collaboration, project management, regulatory system proficiency (TrackWise, Documentum).
Preferred skills
People management, TOPRA certification, RAC qualification.
Technologies
TrackWise, Documentum, Microsoft Office
Responsibilities
Develop global CMC regulatory strategies for injectables; interpret and communicate regulatory requirements; prepare and review CMC submission documentation; support manufacturing sites with variation documentation; manage change controls; collaborate with regional teams on submissions and inspections; respond to health authority queries; mentor colleagues; monitor emerging regulatory trends.
Seniority
Manager, people management experience advantageous