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Senior Regulatory Affairs Manager

Cambridgeshire   •  £75000 - £88000 per annum  •  Permanent, Full time


CK Clinical are recruiting for a Senior Regulatory Affairs Manager to join a Global leading Biotechnology company. The role will work across therapies including biosimilars and lead the regulatory strategy across Europe. A true chance to innovate and lead.

Company:
A top 10 global biotechnology company.

Location:
Uxbridge or Cambridge ? some working from home

Salary:
Circa £80,000 with an excellent package

Responsibilities

  • Lead of team of Regulatory Managers
  • Representing the region, provide advice on regional considerations in developing strategy, and ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders.
  • Plan and manage regulatory submissions (e.g. clinical trial and marketing applications)
  • Implement product related regulatory strategies, Regulatory Affairs processes and activity planning
  • Lead development of regional regulatory documents and meetings
  • Provide regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, PRIME, compassionate use and paediatric plans)
  • Lead Health Authority and Agency Interactions and document and communicate outcomes appropriately

Your Background:

  • Degree in a scientific discipline
  • Extensive experience in regional regulatory environment
  • Proven track record of developing and executing regional regulatory strategy
  • In-depth understanding of the registration procedures in region for MA, post approval changes, extensions and renewals.
  • Ability to lead teams and work collaboratively in a dynamic environment

Apply:
Please quote reference 51068 in all correspondence.

CLINGEN


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

  • Agency: CK Group
  • Contact: Julia Day
  • Phone: 01246 457733
  • Reference: 51068
  • Posted: 8th July 2021
  • Expires: 5th August 2021

CK Group

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