Senior Regulatory CMC strategy manager
Core
Define, coordinate, and implement global CMC regulatory strategies for pharmaceutical products from clinical development through lifecycle management.
Role type
Senior Regulatory CMC Strategy Manager
Builds
Regulatory submission packages (BLAs, INDs, CTAs, MAAs, Variations) for global market entry
Domain
Global pharmaceutical/biotechnological drug development and regulatory affairs
Deliverable
client delivery
Required skills
Global CMC regulatory strategy development, FDA liaison and negotiation, regulatory submission authoring and management, cross-functional risk management, complex scientific problem resolution
Preferred skills
Team management, competing priority management
Technologies
BLAs, INDs, CTAs, MAAs, Variations/Supplements
Responsibilities
Define global CMC regulatory strategies for product development and lifecycle; Liaise directly with US FDA and international health authorities; Negotiate with regulatory authorities for submission acceptance; Manage compliant regulatory CMC documentation; Advise on regulatory strategies and scientific problem interpretation; Facilitate regulatory information flow to stakeholders; Develop timelines and risk management solutions for submissions
Seniority
Senior, hands-on IC with team management
