Regulatory Affairs Manager, Oncology

Location
Uxbridge
Salary
£55000 - £63000 per annum
Posted
08 Jul 2021
Closes
07 Aug 2021
Ref
51069
Contact
Julia Day
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
CK Clinical are recruiting for a Regulatory Affairs Manager to join a Global leading Biotechnology company. The role will support the Oncology group across Europe

Company:
A top 10 global biotechnology company.

Location:
Uxbridge – some working from home

Salary:
Flexible with an excellent package

Responsibilities
  • Plan and manage regulatory submissions (e.g. clinical trial applications, variations and supporting marketing applications)
  • Develop and/or implement innovative and compelling regulatory strategies
  • Lead and/or participate in development of regional regulatory documents
  • Provide regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, PRIME, compassionate use and paediatric plans)
Your Background:
  • Degree in a scientific discipline
  • Relevant experience in Regulatory Affairs
  • Experience in oncology is strongly preferred
  • In-depth understanding of the European registration procedures for MA, post approval changes, extensions and renewals
Apply:

Please quote reference 51069 in all correspondence.

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