Senior Regulatory Affairs Manager, Oncology

Recruiter
CK Group
Location
Uxbridge
Salary
£70000 - £85000 per annum
Posted
19 Aug 2021
Closes
16 Sep 2021
Ref
51067
Contact
Andy Leake
Contract Type
Permanent
Hours
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.

Location:

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.

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

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

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