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Senior Regulatory Affairs Manager

Employer
CK Group
Location
Cambridge
Salary
£70000 - £85000 per annum
Closing date
15 Sep 2021

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Job Details

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.

Location:
Uxbridge or Cambridge – some working from home.

Senior Regulatory Affairs Manager Role:

  • 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:
For more information or to apply for this Senior Regulatory Affairs Manager position, please contact Andy Leake on 01438 842966 or email aleake@ckgroup.co.uk, quoting job ref 51068.

It is essential that applicants hold entitlement to work in the UK.

Company

Find the career you always dreamed of

We are the CK Group, the UK’s specialist in scientific, clinical and technical recruitment.

We have 4 brands:  

  • CK Science is the leading independent scientific recruitment consultancy.
  • CK Clinical is an established leader in the clinical research and drug development sectors
  • CK Technical specialises in jobs for Engineers and IT professionals
  • CK QLS finds roles for high calibre professionals working in the science and technology sectors in Switzerland.

Over the last 28 years we have found jobs for thousands of high calibre scientists in the scientific, chemical, waste, biotechnology and pharmaceutical industries. By working with us to find your next job, you will get access to the best scientific vacancies in the UK, Europe and the rest of the world.

We are proud to be working with 18 out of the world’s top 20 scientific organisations.

We can help you find your dream job.

ckscience.co.uk

Find Us
Website:
Telephone
+44 (0)1246 457700
Location
CK Group
Westwick House
The Bridge Business Centre
Beresford Way
Chesterfield
S41 9FG
GB
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