Regulatory Affairs Manager - Lifecycle Management

Blackfield Associates are actively supporting a client with an immediate requirement for an experience Regulatory professional to join an expanding business based in Slough.

As Regulatory Affairs Manager, you will: Provide subject matter expertise on complex regulatory submissions involving legacy dossiers for solid, liquid and parenteral formulations. The ideal candidate will have significant experience in EU life cycle management and well versed in leading Safety and some CMC variations for products approved via mutual recognition (MRP) and national procedures (NP) and will be capable of leading regulatory strategy and submission execution for established products.

Key Activities / Key Responsibilities: Lead regulatory strategy and submission preparation for Safety and some CMC variations for solid, liquid and parenteral formulations in Europe, UK and Switzerland Review and update outdated Safety and CMC documentation to align with current expectations Serve as Subject Matter Expert for Safety and CMC variations Strategically manage variations between regulatory planning and submission execution

Experience Required: Proven experience with EU regulatory procedur...