Associate Director, CMC Regulatory Affairs, International

The Role

Moderna is looking for an Associate Director, CMC Regulatory Affairs-International, to join our team based in London, UK.

This pivotal role will focus on preparing and overseeing CMC and Quality related agency correspondence and regulatory applications, governing CMC submissions, and providing regulatory compliance support for the development of global products. The successful candidate will lead and support all regulatory activities, ensuring the delivery of high-quality CMC sections of regulatory documentation. This role demands a dynamic individual capable of managing multiple projects in a fast and results-oriented environment, dedicated to bringing a new generation of transformative medicines to patients.

Here’s What You’ll Do

• Developing and implementing effective CMC regulatory strategies for international submissions (e.g., IND/CTA/BLA/MAA) and identifying regulatory risks.
• Providing guidance on regulatory CMC aspects of ...