Senior Manager, Regulatory Affairs (CMC) - Remote

Recruiter
CK Group
Location
Cambridgeshire
Salary
Competitive
Posted
04 Aug 2021
Closes
01 Sep 2021
Ref
51322
Contact
Andy Leake
Contract Type
Permanent
Hours
Full Time
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.

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