£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 a Regulatory Affairs, Senior Manager (CMC) 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.
Specific responsibilities:
- Provision of operational and strategic advice on Chemistry, Manufacturing and Controls (CMC) regulatory affairs to clients for small molecules, biologicals and advanced therapy medicinal products (ATMPs), taking into account regulatory guidelines and applicable pharmacopeial standards as appropriate.
- Preparation of regulatory documents, including Common Technical Document Module 3, Module 2.3, and IMPDs), and CMC aspects of scientific advice briefing documents, paediatric investigation plans and environmental risk assessment documents for genetically modified organisms, plus responses to agency questions.
- Regulatory assessment of change controls.
- Support and/or lead regulatory agency CMC interactions/negotiations to ensure client goals are met.
- Provide support to all ongoing projects and business activities as required, including 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.
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.
About Boyds
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.
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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 recruitment@boydconsultants.com.
No agencies please.
