Director Regulatory Affairs Global CMC
Core
Develop strategic CMC regulatory approaches to expedite preparation and review of regulatory submissions for the L-Upjohn product portfolio.
Role type
Senior IC Director Regulatory Affairs Global CMC
Builds
Global regulatory submissions and compliance for pharmaceutical products
Domain
Pharmaceuticals / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC authoring, people management, project management, cGMP knowledge, regulatory strategy, risk assessment, change control management, stakeholder liaison, technical/scientific analysis, business partnership
Preferred skills
Experience in complex drug development projects, global market regulatory knowledge, negotiation with regulatory authorities, cross-functional leadership
Technologies
None stated
Responsibilities
Cultivate relationships with stakeholders to align regulatory strategies; interpret CMC requirements and develop strategies; prepare and analyze global CMC submission documentation; ensure compliance with external regulatory requirements; serve as liaison with regulatory agencies; present issues for resolution and mentor colleagues; manage CMC responses to MedInfo queries; serve on governance committees; provide guidance and direction to direct reports; review global CMC strategic plans
Seniority
Senior, hands-on IC with people management responsibilities