Senior Regulatory Affairs Manager, Oncology

CK Group
£70000 - £85000 per annum
19 Aug 2021
16 Sep 2021
Andy Leake
Contract Type
Full Time
CK Clinical are recruiting for a Senior Regulatory Affairs Manager to join a Global leading Biotechnology company. The role will work within oncology and lead the regulatory strategy across Europe. A true chance to innovate and lead.


Uxbridge or Cambridge – some working from home.

Senior Regulatory Affairs Manager Role:
  • Lead a team of Regulatory Managers.
  • Representing the region, provide advice on regional considerations in developing strategy, and ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders.
  • Plan and manage regulatory submissions (e.g. clinical trial and marketing applications).
  • Implement product related regulatory strategies, Regulatory Affairs processes and activity planning.
  • Lead development of regional regulatory documents and meetings.
  • Provide regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, PRIME, compassionate use and paediatric plans).
  • Lead Health Authority and Agency Interactions and document and communicate outcomes appropriately.

Your Background:
  • Degree in a scientific discipline.
  • Extensive experience in regional regulatory environment.
  • Proven track record of developing and executing regional regulatory strategy.
  • In-depth understanding of the registration procedures in region for MA, post approval changes, extensions and renewals.
  • Ability to lead teams and work collaboratively in a dynamic environment.
  • Experience in Oncology is strongly preferred.

For more information or to apply for this Senior Regulatory Affairs Manager, Oncology position, please contact Andy Leake on 01438 842966 or email, quoting job ref 51067.

It is essential that applicants hold entitlement to work in the UK.

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