Regulatory Affairs Expert

2 days ago


Cambridgeshire and Peterborough, United Kingdom Boydconsultants Full time

We are seeking a highly skilled Regulatory Affairs Expert to join our team at Boydconsultants. The successful candidate will have experience in leading projects for clients from candidate selection to nonclinical and clinical development, on to marketing authorization and beyond.

Key responsibilities include:

  • Providing strategic regulatory advice to clients, taking into account regulatory guidelines and available measures to facilitate regulatory input, incentives and early market access.
  • Preparing regulatory submission documents, including orphan drug designation applications, scientific advice briefing documents, clinical trial applications and investigational new drug applications.
  • Leading regulatory agency interactions/negotiations to ensure client goals are met.

In return, we offer an opportunity to work with a dynamic team that has significant experience in developing groundbreaking ATMP, biological and small molecule therapies for a range of conditions. We provide a competitive salary of £85,000 per annum, as well as private healthcare, pension and the option to join the Long Term Incentive Plan.



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