Associate Regulatory Affairs Executive - Central Regulatory Affairs (CRA), Europe
Core
Support regulatory submissions, maintain product licenses, and ensure compliance across multiple European markets for a diverse portfolio of pharmaceutical products.
Role type
Associate Regulatory Affairs Executive (Central Regulatory Affairs)
Builds
Regulatory submissions, marketing authorizations, and compliance documentation for pharmaceutical products
Domain
Healthcare / Pharmaceuticals / Regulatory Affairs
Required skills
Regulatory submission preparation, license maintenance, cross-functional collaboration, RIM system management, fee management
Preferred skills
None stated
Technologies
Regulatory Information Management (RIM) systems
Responsibilities
Support regulatory activities for a diverse portfolio of pharmaceutical products across Europe; Assist with the preparation and submission of variations, renewals, and other post-approval regulatory activities; Support the maintenance of marketing authorisations and regulatory compliance activities; Collaborate with local affiliate teams to coordinate regulatory submissions and national regulatory activities; Maintain Regulatory Information Management (RIM) systems and regulatory databases; Support regulatory administration, fee management, and related compliance processes
Seniority
Early-career / Associate
