Senior Manager, Regulatory Affairs CMC
Core
Senior Manager leading global CMC regulatory strategy, compliance, and submission planning for Upjohn's branded pharmaceutical portfolio.
Role type
Senior Manager, Regulatory Affairs (CMC)
Builds
Global regulatory strategies and CMC submissions for new registrations and post-approval changes.
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, risk assessment, project management, stakeholder collaboration, technical writing, regulatory compliance, cross-functional leadership, industry networking
Preferred skills
Subject Matter Expertise in CMC, experience with external regulatory forums
Technologies
Microsoft Office Suite, Documentum
Responsibilities
Ensure global regulatory compliance with external requirements and internal quality procedures; develop and implement global regulatory strategies; prepare and review CMC submissions for new registrations, post-approval changes, and renewals; lead CMC activities including submission planning and risk assessment; represent CMC on cross-functional project teams; maintain regulatory documentation and systems; collaborate with internal and external stakeholders; serve as a technical resource and mentor; support implementation of regulatory policies; build relationships with regulatory authorities.
Seniority
Senior Manager, strategic leadership with hands-on execution