Senior Director, Regulatory Affairs

Job Title: Senior Director, Regulatory Affairs

Job Type: Full-time, permanent position

Location: Cambridge, UK – Hybrid

Remuneration: £130,000 + Benefits

Cpl Life Sciences is collaborating with a prestigious global drug development consultancy business that specializes in supporting pharma, biotechs, spin-outs, and academic groups with drug development activities, focusing on advanced therapies, cell therapy, ATMPS, and other niche therapeutic areas.

As the Senior Director of Regulatory Affairs, you will:

1. Lead client projects, providing strategic regulatory advice, including gap analyses, filing routes, regulatory interactions, and designations (e.g., orphan drug, PRIME/BTD).
2. Prepare regulatory submission documents such as orphan drug designation applications, clinical trial applications, and marketing authorisation applications.
3. Provide leadership to a team of 4 regulatory affairs professionals, supporting development plans and offering training.
4. Lead regulatory agency interactions/negotiations to ensure client goals are met.
5. Complete senior QC review as required.
6. Manage complex regulatory projects, mitigating risks to timelines and budgets.
7. Act as Subject Matter/Functional Area Expert.
8. Draft cost proposals and manage project budgets.
9. Resolve internal/external project issues, escalating to senior management as needed.
10. Work with the Quality function to ensure compliance in regulatory affairs activities.

Requirements for this role:

1. Minimum of a B.Sc. in a life sciences subject; higher degree (PhD) preferred but not essential.
2. At least 12+ years in Regulatory Affairs within a complex therapeutic area.
3. Extensive experience in early-stage drug development.
4. Confident with UK, EU, and US health authorities and drug pathways.
5. Experience with EMA (scientific advice, orphan designation, PIPs).
6. Experienced in driving global Regulatory Affairs Strategies.
7. Experience of bringing a product through EU approval is a distinct advantage.
8. Ability to negotiate and express clear positions to stakeholders.
9. Experience working with national regulatory agencies and leading agency meetings.
10. Excellent written and verbal communication skills.
11. Previous leadership experience and confidence in management.
12. Willingness to support ongoing projects and business activities, including mentoring regulatory staff.
13. Support for business development activities as needed.
14. Maintain up-to-date regulatory knowledge and contribute to the company’s regulatory intelligence function.

This role requires an office presence (2/3 days on-site per week) due to its leadership nature.

For more information, please contact lucy.kirkaldy@cpl.com.