CMC Regulatory Specialist
Ipsen
Date: 11 hours ago
City: Wrexham, Wales
Contract type: Full time
At Ipsen, we are committed to improving the lives of patients, with a special focus on advancing neuroscience therapies. Our Wrexham site is a vital part of this mission, delivering cutting-edge solutions in a dynamic and collaborative environment. We are proud to be Great Place to Work certified and a Shingo Bronze Medallion holder, reflecting our commitment to excellence, innovation, and continuous improvement.
With a recent £24 million investment in the site and a further £86.4 million expansion underway, there has never been a more exciting time to join us. If you are passionate about making an impact and want to be part of a team that values growth, innovation, and excellence, then Ipsen could be where you thrive!
We seeking an experienced and motivated Expert in CMC Regulatory Strategy to join our Global Regulatory Affairs team. In this role, you will contribute to the development and execution of Chemistry, Manufacturing and Controls (CMC) regulatory strategies for both new and existing pharmaceutical products. You will play a key part in preparing high-quality regulatory submissions that support global product development, registration, and lifecycle management.
Key Responsibilities
With a recent £24 million investment in the site and a further £86.4 million expansion underway, there has never been a more exciting time to join us. If you are passionate about making an impact and want to be part of a team that values growth, innovation, and excellence, then Ipsen could be where you thrive!
We seeking an experienced and motivated Expert in CMC Regulatory Strategy to join our Global Regulatory Affairs team. In this role, you will contribute to the development and execution of Chemistry, Manufacturing and Controls (CMC) regulatory strategies for both new and existing pharmaceutical products. You will play a key part in preparing high-quality regulatory submissions that support global product development, registration, and lifecycle management.
Key Responsibilities
- Support the creation and implementation of global CMC regulatory strategies.
- Coordinate, author, and review CMC sections of regulatory submissions (e.g., INDs, IMPDs, MAAs, CTAs).
- Ensure submissions are compliant with global regulatory requirements and Ipsen standards.
- Collaborate with cross-functional teams including Pharmaceutical Development, Technical Operations, and Regulatory Affairs.
- Monitor regulatory changes and contribute to regulatory intelligence activities.
- Respond to regulatory authority questions and support inspections as needed.
- Maintain accurate documentation and submission trackers.
- Previous experience in a similar role from the pharmaceutical industry
- Degree in a relevant subject or equivalent experience
- Fluent in English, French is preferred
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