Manager Regulatory CMC Sciences (Injectables)
Core
Develop and implement global CMC regulatory strategies for injectable products, ensuring compliance and managing lifecycle submissions.
Role type
Manager, Regulatory CMC Sciences (Injectables)
Builds
Global regulatory submissions and lifecycle management for injectable pharmaceutical products.
Domain
Pharmaceuticals / Regulatory Affairs / CMC
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global CMC regulatory strategy, injectable/parenteral product expertise, post-approval lifecycle management, US FDA regulations, cGMP/CFR/USP/Ph. Eur. knowledge, cross-functional collaboration, regulatory documentation, project management
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 strategies; ensure compliance via change control management; collaborate with regional teams on submissions and inspections; respond to health authority queries; mentor colleagues; monitor emerging regulatory trends.
Seniority
Manager, hands-on IC with team leadership