Regulatory Affairs Senior Manager
£Competitive | Cambridge, UK
Boyds is looking to hire an experienced, enthusiastic and motivated regulatory affairs professional to join us and support the future growth of our busy regulatory consultancy, working across a range of product types and therapeutic indications in both the EU and US.
In this role, you will use your existing skills and knowledge to lead projects for clients from candidate selection to nonclinical and clinical development and 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
- Maintain up to date regulatory knowledge and contribute to the company’s regulatory intelligence function.
The successful candidate will have:
- At least 5 years’ experience gained in a consultancy environment, with a minimum of a B.Sc. in a life sciences subject (a higher degree would be a distinct advantage)
- Experience in the writing of strategic regulatory documents for the EU is essential; US experience is a distinct advantage
- 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, biological and small molecule therapies for a range of conditions, many of which are rare diseases. We are a small, friendly, efficient and effective team and can help you to grow your future career in a professional and varied environment.
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.
Closing date for applications: 31 March 2019