Job Description
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 specialises in supporting pharma, biotechs, spin-outs, and academic groups with drug development activities. The business has a specific focus on advanced therapies, cell therapy, ATMPS, and other niche and challenging therapeutic areas.
As the Senior Director of Regulatory Affairs, you will provide support to the Regulatory Affairs team across a range of projects. You will work closely with the Vice President of Regulatory Affairs to oversee the team.
Responsibilities for this role include:
1. Lead client projects, providing strategic regulatory advice to clients, taking into account regulatory guidelines and available measures to facilitate regulatory input, incentives and early market access (such activities will include gap analyses, advice on filing routes, timings, regulatory authority interactions, paediatric development, orphan drug designation and PRIME/Breakthrough Therapy or Regenerative Medicines Advanced Therapy Designation [BTD/RMAT] applications).
2. Preparation of regulatory submission docu...