Regulatory CMC Consultant - Six Month contract. INSIDE IR35
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 CMC Consultant, 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 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* Review and update outdated Safety and CMC documentation to align with current expectations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 procedures, especially MRP/DCP/NP
* Significant hands-on experience of preparing and submitting Safety and CMC variations and familiar with European regulatory requirements
* Ability to work independently and advise on best practices for legacy dossier life cycle management
* Strong understanding of regulatory strategy development and cross-functional coordination
* Available immediately and able to commit through to December 2025
Ideal candidates will be immediately available / short notice.
Must be able to work from site 2 days a week.
Unable to sponsor, all applicants must hold valid Right to Work status for the UK.