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Regulatory Affairs Specialist

3 months ago

London, Greater London, United Kingdom Apsida Life Science Full time
Regulatory Affairs Specialist - Lifecycle MaintenancenLocation: Remote

We are seeking an experienced Regulatory Affairs Specialist to oversee lifecycle maintenance for our mature product portfolio.

The successful candidate will manage compliance activities, coordinate with EU member states under the MRP, handle national product regulations, and ensure all documentation and artwork meet regulatory standards.


Key Responsibilities:

nLifecycle Management:
Ensure continuous compliance of mature products, manage documentation for product variations and renewals

nMRP Product Management:
Coordinate regulatory approvals across EU member states, maintain up-to-date documentation aligned with MRP requirements

nNational Product Compliance:
Manage all aspects of regulatory compliance for products authorized at the national level, including liaising with the MHRA and other health authorities

nDocument Preparation:
Update and maintain critical documents such as labels, patient information leaflets, and summaries of product characteristics

nArtwork Oversight:
Manage the creation, revision, and approval of product packaging artwork to ensure compliance with regulatory guidelines

nArchiving:
Implement and maintain a robust document archiving system that meets regulatory data retention standards.