Senior Regulatory Affairs Manager, Oncology

  • Salary: £70,000 - £85,000
  • REF Number: 00051067
  • Consultant: Andy Leake
  • Contact: 01438 842 966
  • Date Published: 14.12.2021
  • Sector: Biotechnology
  • Location: Uxbridge, UK, London, Home Counties
  • Discipline: Regulatory Affairs

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.itlement to work in the UK is essential.experience within a pharmaceutical/bio-tech company (medical department/non-promotional)

  • Sufficient scientific expertise to understand the oncology therapy area in terms of emerging scientific trends, drug development, market demands and patient needs.
  • Experience of building and maintaining strong relationships with KOLs and forming networks
  • Demonstrate flair, enthusiasm, innovation and an ability to be a self-starter.
  • Low ego with strong EQ skills – able to network and interact with very senior global oncologists and endear them to the Ellipses mission

Apply:

Entitlement to work in the UK is essential. For more information or to apply for this Oncology Scientific Liaison role, please contact Julia Day on 01246 457719 or email jday@ckgroup.co.uk. Alternatively, please click on the link below to apply online now. Please quote reference 52033 in all correspondence.

CLINGENe.

  • Good understanding of current UK health care system and market access issues
  • Demonstrated experience of project management
  • Strong numeric skills
  • Scientific/medical knowledge
  • A commercial mindset

Apply: Entitlement to workin the UK is essential. For more information or to apply for this Health Economics Manager position, please contact Steve Lord on 01246 457733 or email slord@ckgroup.co.uk. Please quote reference 52358 in all correspondence.

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