Head of Regulatory CMC – Consultancy (Remote, UK)

Barrington James; Greater London; Remote; GBP 125,000 - 150,000

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:

• Lead Regulatory CMC strategy and execution for a diverse portfolio of biologics, small molecules, and ATMPs.
• Prepare, review, and author Module 3 and other technical dossier submissions, ensuring compliance with global regulatory requirements.
• Provide expert guidance on Scientific Advice interactions with health authorities.
• Support clients in navigating regulatory challenges across product lifecycles.
• Contribute to business development, identifying new opportunities and fostering client relationships.

About You:

• 10+ years' experience in Regulatory CMC within pharmaceuticals, biotech, or consultancy.
• Strong expertise in biologics and small molecules; experience with ATMPs is highly desirable.
• Proven experience in Scientific Advice interactions and authoring/reviewing Module 3 and technical dossiers.
• Interest or experience in business development, with the ability to engage with potential clients.
• Ability to work independently in a remote setting while collaborating with a global team.

What We Offer:

• A flexible remote role with the opportunity to work on groundbreaking therapies.
• A collaborative, expert-driven environment where your insights shape regulatory strategies.
• Competitive compensation and professional development opportunities.

If you're ready to take on a high-impact role that blends Regulatory CMC expertise with business development, apply today!

Seniority level

Director

Employment type

Full-time

Job function

Science and Consulting

Industries

Biotechnology Research and Pharmaceutical Manufacturing