Executive Director, Regulatory CMC

Executive Director, Regulatory CMC – London Area (Hybrid)

Our client, a mid-sized pharmaceutical company, are looking for an Executive Regulatory CMC Director (Small molecule focus) with a passion for leadership, driving strategy, ensuring compliance with EMA and FDA regulations, whilst fostering innovation and operational excellence.

The Client

The company is based in the London area and cover a number of therapeutic areas in small and large molecule products. They are dedicated to developing cutting-edge therapies that improve lives, have a strong global footprint, and are committed to regulatory excellence and delivering high-quality products to patients worldwide.

The Role

As Executive Director of Regulatory CMC, you will:

• Lead CMC regulatory strategies for global submissions (EMA, FDA, and beyond).
• Oversee the preparation and review of regulatory submissions (IND, NDA, BLA, MAA), as well as post approval activities.
• Drive collaboration with cross-functional teams, ensuring compliance and efficiency in drug development.
• Provide strategic guidance on CMC regulatory matters, shaping the regulatory landscape for the company’s pipeline.
• Represent the company in regulatory agency interactions, influencing outcomes in alignment with business goals.

Experience

• Proven leadership experience in Regulatory CMC within the pharmaceutical industry.
• Expert knowledge of EMA and FDA regulatory requirements.
• Strong background in small molecule drug development.
• Exceptional communication and stakeholder management skills.
• Ability to drive innovation while ensuring regulatory compliance.

To apply, please contact me at rhi@greenlsr.com