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Senior Manager, Regulatory Affairs (CMC) - Remote

Employer
CK Group
Location
Cambridgeshire
Salary
Competitive
Closing date
1 Sep 2021

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Sector
Regulatory Affairs
Contract Type
Permanent
Hours
Full Time

Job Details

CK Clinical are recruiting for a Senior Manager, Regulatory Affairs (CMC) to join a leading Advanced Therapy Consultancy. This is a permanent position to join an award-winning Regulatory team. Remote working can be considered in the UK.

Senior Manager, Regulatory Affairs (CMC) Role:

As Senior Manager, Regulatory Affairs (CMC) you will independently lead regulatory projects in a client-facing position. This will involve developing regulatory strategy for Advanced Therapies (ATMP), Biologicals or Small Molecules.

Key duties will include:
  • Developing and implementing Regulatory CMC strategy.
  • Performing Regulatory activities for projects.
  • Preparation of regulatory documents including CTD Module 3, 2.3, IMPDs as well as other CMC related documents.
  • Leading and/or supporting regulatory agency interactions.
  • Leading client interactions.

Your Background:
As Senior Manager, Regulatory Affairs (CMC) you will require:
  • At least a Life Sciences degree.
  • Proven CMC Regulatory Affairs experience within the pharmaceutical industry. Experience within consultancies is a bonus.
  • Experience working with ATMPs or Biologics is essential.
  • Extensive experience leading the development of Regulatory Strategy.
  • Strong experience writing operational and strategic CMC documents.
  • Self-starter attitude, with the ability to independently find creative solutions for complex problems.

Apply:
For more information or to apply for this Senior Manager, Regulatory Affairs (CMC) position, please contact Andy Leake on 01438 842966 or email aleake@ckgroup.co.uk, quoting job ref 51322.

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

CLINGEN

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

Company info
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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