Regulatory Affairs Manager CMC
Core
Independently prepare regulatory assessments and contribute to global regulatory strategies for the Upjohn product portfolio across the drug development and manufacturing lifecycle.
Role type
Manager, Regulatory Affairs (CMC)
Builds
Global regulatory strategies and CMC submissions for Upjohn brand-name products
Domain
Pharmaceuticals / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC authoring, regulatory strategy development, project management, cGMP assessment, technical/scientific resource provision
Preferred skills
Master's degree, experience in Quality/Technical Services/R&D
Technologies
Microsoft Office Suite, Documentum
Responsibilities
Ensure global regulatory conformance and consistency; develop robust regulatory strategies to mitigate risk; prepare and manage CMC regulatory submissions; serve as CMC representative on core project teams; manage regulatory issues and track commitments; author/coordinate CMC activities for registrations and post-approval changes; provide technical guidance and mentor colleagues; build relationships with R&D, Quality, and Regulatory teams.
Seniority
Manager, hands-on IC
