Regulatory Affairs Director
21 hours ago
Clinical Professionals Limited is seeking an experienced Regulatory Affairs Director to join their team. This role will provide strategic regulatory advice to clients, taking into account regulatory guidelines and available measures to facilitate regulatory input, incentives, and early market access.
As a Senior Regulatory Professional, you will lead client projects, preparing regulatory submission documents including orphan drug designation applications, scientific advice briefing documents, clinical trial applications, investigational new drug applications, PIPs/PSPs, PRIME/Breakthrough Therapy or Regenerative Medicines Advanced Therapy Designation [BTD/RMAT] applications.
The estimated salary for this role is £130,000 + Benefits. The location of the job is Cambridge, UK – Hybrid, requiring 2/3 days on site per week.
The ideal candidate will have at least 12+ years in Regulatory Affairs within a complex therapeutic area, with experience in dealings with the EMA (scientific advice, orphan designation, PIPs) and driving global Regulatory Affairs Strategies.
About the Role- Lead client projects, providing strategic regulatory advice
- Prepare regulatory submission documents
- Provide leadership to a team of regulatory affairs professionals
- Lead regulatory agency interactions/negotiations
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