Regulatory Affairs Manager

Location
Uxbridge
Salary
Up to £42.59 ph PAYE
Posted
14 May 2021
Closes
13 Jun 2021
Ref
50640
Contact
Dennis Beltman
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Management
CK Group are recruiting for a Regulatory Affairs Manager to join a biopharmaceutical company at their site based in Uxbridge on a contract basis for 6 months.

Salary:
Up to £42.59 ph PAYE

Regulatory Affairs Manager Role:
  • Planning and managing regulatory submissions (e.g. clinical trial and marketing applications) for products within the clients portfolio
  • Developing and/or implementing innovative and compelling regulatory strategies designed to enable patient access, following regulatory affairs processes and activity planning in accordance with national legislation and regional regulatory requirements.
  • Providing 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:
  • Relevant experience with regulatory activities in the EU region including clinical trials (CTAs) and registration procedures (MAs, post approval changes, extensions and renewals).
  • Good knowledge of and experience in regional regulatory environment in relevant product area and development stage
  • Ability to anticipate regulatory agency responses to strategy
  • Awareness of the needs of internal and external stakeholders, and the role of Regulatory Affairs in driving successful drug development
  • Experience with EU and national legislation and regulations relating to medicinal products
Company:
Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.

Location:
This Regulatory Affairs Manager role will be based at our clients site in Uxbridge, Greater London.

Apply:
Please quote reference 50640.

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