Director, Regulatory Affairs CMC
Core
Strategic and operational leadership for Regulatory CMC to support clinical trial applications, market registrations, and post-approval submissions for small molecule pharmaceuticals.
Role type
Director, Regulatory CMC
Builds
Regulatory dossiers and submission strategies for clinical and commercial products
Domain
Biopharmaceuticals / Small molecule drug development
Deliverable
client delivery
Required skills
Regulatory CMC strategy, global health authority interaction, CMC dossier content definition, risk management, global regulatory requirements knowledge, small molecule life cycle management
Preferred skills
Advanced degree in life sciences, broad-based CMC technical and product experience
Technologies
None stated
Responsibilities
Develop and lead execution of regulatory CMC strategies for assigned products; Represent the Regulatory CMC function in Health Authority meetings; Provide global regulatory input to quality-related activities; Monitor and communicate relevant global CMC regulatory requirements and trends
Seniority
Director, strategic & operational leadership
