£Competitive | UK based
Boyds is looking for experienced, enthusiastic and motivated regulatory affairs professionals to join our award-winning regulatory team and support the future growth of our busy regulatory consultancy, working across a range of product types and therapeutic indications in the UK, EU and US.
As a Senior Director working alongside the Vice President of Regulatory Affairs, you will use your existing skills and knowledge to lead projects for clients from candidate selection to nonclinical and clinical development and to marketing authorization and beyond.
Specific responsibilities:
- Work with and deputize for the Vice President, Regulatory Affairs, on team development, growth and structure, including quality management and project oversight
- 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, pediatric development, orphan drug designation and PRIME/Breakthrough Therapy Designation [BTD/RMAP] applications).
- Preparation of regulatory submission documents including orphan drug designation applications, scientific advice briefing documents, clinical trial applications and investigational new drug applications, pediatric investigation plans, pediatric study plans, PRIME/BTD/RMAT and marketing authorization applications.
- Lead regulatory agency interactions/negotiations to ensure client goals are met.
- Lead on complex, multifactorial regulatory projects
- Act as subject matter/functional area expert
- Provide support to business activities as required, including drafting of cost proposals, tracking of budgets and managing projects to time and budget
- Resolve internal and external project issues as needed
- Work with Boyds Quality function to ensure applicability and compliance for all regulatory affairs activities
The successful candidate will have:
- Proven 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). Ideally, around 15 years of relevant experience or equivalent expertise in Regulatory Affairs would be desirable
- Experience in the writing of strategic regulatory documents
- Experience in cell and gene therapies and small molecules
- 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 written and verbal communication skills
- Knowledge of the evolving regulatory environment, including proposed changes to legislation that may impact on our business and that of our clients
- Strong leadership and project management experience
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 growing global drug development consultancy with a friendly, efficient and effective team and can help you to grow your future career in a professional and varied environment. Upon successful completion of the probation period, Boyds team members are eligible for a range of attractive benefits including bonus, private healthcare, pension and the option to join the Share Incentive Scheme.
About Boyds
Boyds is a fast-growing global drug development consultancy providing a range of expertise and skills central to the development of pharmaceutical and biotechnology medicinal products and medical devices. Based in the UK, EU and US with offices in Cheshire, Cambridgeshire, Dublin and Pennsylvania, Boyds has an international client base comprising of early stage life science and medical device companies, pharma companies and academic groups.
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If you are interested in joining our award-winning regulatory team, please state the role you are applying for in the email subject line, and 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.
