Manager CMC Regulatory Affairs
Core
Manage regulatory submission forms and documentation for clinical trials to support the release of investigational product to global health authorities.
Role type
Manager, CMC Regulatory Affairs
Builds
Regulatory submission packages for clinical trials
Domain
Biopharmaceutical manufacturing and regulatory compliance
Deliverable
client delivery
Required skills
Regulatory submission management, cross-functional collaboration, team leadership, compliance background, program management, process improvement, stakeholder communication, quality principles in regulated environments
Preferred skills
Advanced degree in Chemistry or Biology, strong compliance background, program management experience
Technologies
None stated
Responsibilities
Contribute to the management of the regulatory submission form process, support cross-functional departments in understanding the regulatory landscape, participate in cross-functional meetings to identify CMC regulatory issues, develop procedures for tracking regulatory submission packages, lead meetings and presentations on complex regulatory issues, keep management informed of project status, act as a submission compliance liaison, manage and lead a team
Seniority
Manager, 2+ years leadership experience
