Head of regulatory cmc - consultancy (remote, uk)

Job Description

Head of Regulatory CMC – Consultancy (Remote, UK)

Are you a seasoned Regulatory CMC professional with expertise in biologics, small molecules, and ATMPs? Do you thrive in a dynamic consultancy environment and have a passion for business development? If so, we want to hear from you!


About Us

We are a leading regulatory consultancy, supporting innovative life sciences companies in bringing their products to market. Our expert team provides strategic guidance across the regulatory landscape, from early development to post-approval.


The Role

We are looking for an experienced Head of Regulatory CMC to join our team on a full-time, remote basis within England. This role offers the opportunity to work on cutting-edge biologics, small molecules, and ATMPs, while also contributing to our business development efforts.


Key Responsibilities:

1. Lead Regulatory CMC strategy and execution for a diverse portfolio of biologics, small molecules, and ATMPs.
2. Prepare, review, and author Module 3 and other technical dossier submissions, ensuring compliance with global regulatory requirements.
3. Provide expert guidance on