Global Regulatory Lead

4 days ago


Cambridgeshire and Peterborough, United Kingdom Clinical Professionals Limited Full time

Clinical Professionals Limited is a growing business that supports pharmaceuticals, biotechs, spin-outs, and academic groups to translate science into medicinal products. We are seeking a highly skilled Global Regulatory Lead to join our team and lead our regulatory affairs strategy.

As a Global Regulatory Lead, you will be responsible for leading client projects, providing strategic regulatory advice, and handling various regulatory affairs tasks. You will have the opportunity to work on complex regulatory projects, including the preparation of regulatory submission documents, such as orphan drug designation applications, scientific advice briefing documents, Clinical Trial Authorisation (CTA) and Investigational New Drug (IND) applications, Paediatric Investigation Plans (PIPs)/Pediatric Study Plans (PSPs), PRIME/Breakthrough Therapy or Regenerative Medicines Advanced Therapy Designation [BTD/RMAT] applications, and Marketing Authorisation Applications.

The ideal candidate will have at least 10 years of industry experience in a regulatory role, with prior experience in a CRO/pharmaceutical environment. You will have extensive experience driving global regulatory strategies and be able to maintain up-to-date regulatory knowledge to contribute to our company's regulatory intelligence function.

This is a permanent, full-time position based in Cambridge, UK, with the opportunity to work remotely. The salary range for this role is £80,000 - £110,000 per annum, depending on experience.



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