Regulatory Affairs Specialist

4 weeks ago


Cambridgeshire and Peterborough, United Kingdom Boydconsultants Full time

Regulatory Affairs Role Overview

Boyds, a leading global drug development consultancy, is seeking an experienced Regulatory Affairs Specialist to join its award-winning regulatory team. This is an exciting opportunity for a motivated and enthusiastic professional to support the growth of our busy regulatory consultancy.

The ideal candidate will have existing skills and knowledge in regulatory affairs, with the ability to lead projects for clients from candidate selection to nonclinical and clinical development and to marketing authorization and beyond.

  • Provide strategic regulatory advice to clients, taking into account regulatory guidelines and available measures to facilitate regulatory input, incentives, and early market access.
  • Prepare regulatory submission documents, including orphan drug designation applications, scientific advice briefing documents, and clinical trial applications.
  • Lead regulatory agency interactions and negotiations to ensure client goals are met.
  • Support ongoing projects and business activities as required, including mentoring of other team members.
  • Maintain up-to-date regulatory knowledge and contribute to the company's regulatory intelligence function.

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. With offices in the UK, EU, and US, we have an international client base comprising early stage life science and medical device companies, pharma companies, and academic groups.



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