• We use cookies to help make our website work. LEARN MORE

Regulatory Affairs Manager, Oncology

Middlesex   •  £55000 - £63000 per annum  •  Permanent, Full time


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.


You must be eligible to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Julia Day
  • Phone: 01246 457733
  • Reference: 51069
  • Posted: 8th July 2021
  • Expires: 5th August 2021

CK Group

Share this job: