£Competitive | UK based
Boyds is a dynamic and growing organisation that provides specialist consultancy services to a wide range of clients, and we specialize in supporting the development of advanced therapy medicinal products (ATMPs), small molecules and biologics across a wide range of therapeutic areas to support the development of new medicines for patient benefit.
We are currently looking for an Associate Director to join our award-winning regulatory team. In this role, you will provide support to the Boyds’ Regulatory Affairs team across a dynamic range of regulatory projects and therapeutic areas as needed to support the group’s regulatory services and activities.
- 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.
- Line management of regulatory staff as needed.
The successful candidate will have:
- Minimum of a B.Sc. in a life sciences subject and/or a higher degree
In return, we can offer an opportunity to work with a team with significant experience in developing groundbreaking ATMP (including gene therapies), biological and small molecule therapies for a range of conditions, many of which are in the rare disease and oncology therapy areas. We are a growing, friendly, efficient and effective team and can help you to grow your future career in a professional and varied environment.
Boyds is a fast-growing consultancy business providing a range of expertise and skills central to the development of pharmaceutical and biotechnology medicinal products and medical devices. Headquartered in the UK with offices in Cheshire, Cambridgeshire, Dublin and Pennsylvania, Boyds has an international client base comprising of early-stage life science and medical device companies as well as Universities.
Boyds has earned a reputation for its work in advanced therapies and in 2018, the company was awarded the prestigious Queen’s Award for Enterprise, International Trade for outstanding short-term growth in overseas sales.
If you are interested in joining us, please send your CV and a short description of why you enjoy working in regulatory affairs and the difference you believe you could make for our clients to firstname.lastname@example.org.
No agencies please.