Boyds is a dynamic and growing organisation that provides specialist consultancy services to a wide range of clients, and we specialise 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 a Regulatory Affairs Director or Associate Director (depending on experience) to join our award-winning regulatory team and support the company’s further growth, and can offer excellent opportunities for your own growth and development.
In this role, you will use your existing skills and knowledge to lead projects for clients from candidate selection to nonclinical and clinical development, on to marketing authorisation and beyond. This role will generally consist of the following activities:
Provision of 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 Designation [BTD] applications)
Preparation of regulatory submission documents including orphan drug designation applications, scientific advice briefing documents, clinical trial applications and investigational new drug applications, paediatric investigation plans, PRIME/BTD and marketing authorisation applications
Lead regulatory agency interactions/negotiations to ensure client goals are met
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.
Opportunities for line management of regulatory staff
The successful candidate will have:
At least 7 years’ experience gained in a consultancy environment, with a minimum of a BSc in a life sciences subject and/or a higher degree
Experience with ATMPs
Experience in the writing of strategic EU and US regulatory documents and some regulatory CMC experience
Proven capability in developing effective, timely and tailored regulatory strategies across a range of products and therapeutic areas
Flexibility to adapt to working with a range of clients (e.g. virtual/spinout companies, academic groups, SMEs and mid-size pharma) is an advantage
Excellent communication skills (written and verbal)
Knowledge of the evolving regulatory environment, including proposed changes to legislation that may impact on our business and that of our clients
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.
We currently have vacancies in the regulatory team, however we are always interested to hear from experienced individuals that are looking to develop their career with Boyds.
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 email@example.com.
No agencies please.