Regulatory Affairs Specialist

Full Job Description

Regulatory Affairs Specialist - Lifecycle Maintenance

Location: 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:

• Lifecycle Management: Ensure continuous compliance of mature products, manage documentation for product variations and renewals.
• MRP Product Management: Coordinate regulatory approvals across EU member states, maintain up-to-date documentation aligned with MRP requirements.
• National Product Compliance: Manage all aspects of regulatory compliance for products authorized at the national level, including liaising with the MHRA and other health authorities.
• Document Preparation: Update and maintain critical documents such as labels, patient information leaflets, and summaries of product characteristics.
• Artwork Oversight: Manage the creation, revision, and approval of product packaging artwork to ensure compliance with regulatory guidelines.
• Archiving: Implement and maintain a robust document archiving system that meets regulatory data retention standards.