Senior Manager, Regulatory Affairs CMC
Core
Senior Manager leading global CMC regulatory strategy, compliance, and submission preparation for the Upjohn branded portfolio.
Role type
Senior Manager, Regulatory Affairs (CMC)
Builds
Global regulatory strategies and CMC submissions for new registrations and post-approval changes.
Domain
Healthcare / Pharmaceuticals / Regulatory Affairs
Required skills
CMC authoring, regulatory strategy, risk assessment, project management, stakeholder collaboration, technical writing, regulatory compliance, cross-functional leadership, industry networking.
Preferred skills
Subject Matter Expert experience, mentoring capabilities, external forum participation.
Technologies
Microsoft Office Suite, Documentum
Responsibilities
Ensure global regulatory compliance, develop global regulatory strategies, prepare and review CMC submissions, lead CMC project activities, represent CMC on cross-functional teams, maintain regulatory documentation, collaborate with internal/external stakeholders, serve as technical resource and mentor, support policy implementation, build relationships with regulatory authorities.
Seniority
Senior Manager, strategic leadership with hands-on execution