Job Title: Associate Director, Regulatory Affairs
Job Type: Permanent, full-time
Locations: Cambridge, UK – Hybrid/Remote
Remuneration: £85,000 - £110,000 + benefits
An opportunity to join a growing business that supports pharmaceuticals, biotechs, spin-outs and academic groups to translate science into medicinal products. In this role as an Associate Director, Regulatory Affairs will lead strategy for development programs globally, support all area's of development and support any area of regulatory affairs.
The right profile will have a strong regulatory background with a keen interest in drug development, while also wanting to be hands on with all regulatory activities and confident communicator who is able to influence at all levels.
Key Responsibilities:
- 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).
- Preparation of regulatory submission documents including orphan drug designation applications, scientific advice briefing documents, Clinical Trial Authorisation (CTA) and Investigational New Drug (IND) applications, Paediatric Investigation Plans (PIPs)/Pediatric Study Plans (PSPs), PRIME/BTD/RMAT and Marketing Authorisation Applications.
- Lead regulatory agency interactions/negotiations to ensure client goals are met.
- Completes Senior Quality Control (QC) review as required.
- Leads on complex, multifactorial regulatory projects requiring input from several functions and takes the necessary actions to highlight and mitigate potential risks to timelines, budget and deliverables for clients.
- May act as Subject Matter/Functional Area Expert.
- Provide support to all ongoing projects and business activities as required, including mentoring of other members of the team as appropriate, and business development activities as needed (e.g. calls with potential clients, and support for activities such as conferences, exhibitions and seminars).
- Maintain up to date regulatory knowledge and contribute to the company's regulatory intelligence function.
Qualification requirements
- Minimum of a B.Sc. in a life sciences subject and/or a higher degree.
- At least 10 years of industry experience in a regulatory role required.
- Prior experience in a CRO/pharmaceutical environment required.
- Extensive experience driving global regulatory strategies.
If you are interested in this role or would like more details please email your CV to
Remember if this role is not suitable for you please feel free to forward this to anyone you feel would be suitable. If we successfully find a role for your recommendation we will give you £250 in vouchers of your choice.