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Regulatory Affairs Manager

Middlesex   •  Permanent, Full time

CK Clinical are recruiting for a Regulatory Affairs Manager to join a Global leading Biotechnology company. The role will support the general medicine group across Europe.

A top 10 global biotechnology company.

Uxbridge ? some working from home

Flexible with an excellent package

? 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
? In-depth understanding of the European registration procedures for MA, post approval changes, extensions and renewals

Entitlement to work in the UK is essential. Please quote reference 51070.

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

  • Agency: CK Group
  • Contact: Julia Day
  • Phone: 01246 457733
  • Reference: 51070
  • Posted: 7th July 2021
  • Expires: 4th August 2021

CK Group

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