£Competitive | UK or US locations considered
Boyds is looking for an experienced, enthusiastic and motivated regulatory affairs professional 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.
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 authorization and beyond.
Specific responsibilities:
* 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, 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.
* 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.
* 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.
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.
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.
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.
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