Director Regulatory Affairs Global CMC
Core
Director leading global CMC regulatory strategy, submissions, and compliance for the L-Upjohn product portfolio.
Role type
Senior IC Director (Regulatory Affairs)
Builds
Global regulatory submissions and compliance strategies for pharmaceutical products
Domain
Pharmaceuticals / Regulatory Affairs
Required skills
CMC authoring, people management, project management, cGMP knowledge, regulatory strategy, risk assessment, stakeholder management, change control, agency liaison, training delivery
Preferred skills
Matrixed team leadership, complex project execution, global market strategy, negotiation with authorities, cross-functional partnership
Technologies
Regulatory submission systems, CMC documentation tools
Responsibilities
Develop strategic CMC regulatory approaches, interpret CMC requirements, prepare submission documentation, serve as liaison with regulatory agencies, manage CMC change control, mentor colleagues, lead cross-functional projects, execute training activities, serve on governance committees
Seniority
Senior, hands-on IC with people management responsibilities