Chef de Projet Affaires Règlementaires CMC F/H
Core
Define and execute CMC regulatory strategy for product development and lifecycle management, coordinating submissions with health authorities across Europe and international zones.
Role type
Senior Regulatory Affairs Project Manager (CMC)
Builds
Regulatory dossiers (Module 3, 2.3, CTAs, PIP, SA, ODD, ATU) and post-authorization compliance documentation for plasma-derived and recombinant protein medicines.
Domain
Pharmaceutical industry, CMC (Chemistry, Manufacturing, and Controls), Regulatory Affairs
Required skills
CMC regulatory strategy, Module 3/2.3 dossier preparation, health authority liaison, post-authorization compliance, regulatory database management, quality documentation, stakeholder coordination
Preferred skills
Life-cycle management (LCM), international regulatory submissions, expert coordination
Technologies
XEVMPD, GED (Electronic Document Management), regulatory databases
Responsibilities
Contribute to CMC regulatory strategy based on health authority interactions; Define CMC variation registration strategy; Coordinate preparation and submission of regulatory modules; Follow up on regulatory requests with European and international authorities; Ensure post-AMM obligations and renewal requests; Maintain regulatory quality documentation and traceability.
Seniority
Senior, hands-on IC