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

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.

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

Apply:
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

Share this job: