Reference Number: JO-2410-541870
Associate Director, Regulatory Affairs
Rate: Negotiable
Job Type: Permanent
Location: Cambridge
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, you will lead strategy for development programs globally, support all areas of development, and handle various regulatory affairs tasks.
The right profile will have a strong regulatory background with a keen interest in drug development, and a desire to be hands-on with all regulatory activities. A confident communicator who can influence at all levels is essential.
Key Responsibilities:
* Lead client projects, providing strategic regulatory advice while considering regulatory guidelines and measures to facilitate regulatory input, incentives, and early market access (including 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).
* Prepare 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.
* Complete Senior Quality Control (QC) review as required.
* Lead on complex, multifactorial regulatory projects requiring input from several functions, and take 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 ongoing projects and business activities as required, including mentoring of team members and participating in business development activities (e.g., calls with potential clients, support for 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 lucy.kirkaldy@cpl.com.
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