Ready to shape the future of healthcare by ensuring life-changing treatments meet global regulatory standards? Join our client, a leader in pharmaceutical innovation, and make a meaningful impact!
Proclinical is seeking a Regulatory CMC Contractor to provide expertise in regulatory submissions for solid, liquid, and parenteral formulations. This role focuses on lifecycle management in the EU, UK, and Switzerland, with an emphasis on leading variations for products approved through mutual recognition (MRP) and national procedures (NP). You will play a key role in shaping regulatory strategies and ensuring compliance with current standards.
Responsibilities:
* Lead regulatory strategy and CMC submission preparation for solid, liquid, and parenteral formulations across Europe, the UK, and Switzerland.
* Review and update outdated CMC documentation to meet current regulatory expectations.
* Act as a Subject Matter Expert for CMC variations.
* Balance strategic regulatory planning with submission execution.
Key Skills and Requirements:
* Strong knowledge of EU regulatory procedures, including MRP, DCP, and NP.
* In-depth understanding of CMC regulatory requirements and ICH guidelines.
* Hands-on experience preparing CMC variations and navigating European regulatory frameworks.
* Ability to work independently and provide guidance on legacy dossier lifecycle management.
* Expertise in developing regulatory strategies and coordinating cross-functional teams.
If you are having difficulty in applying or if you have any questions, please contact Pete Duvall at p.duvall@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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