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| Job Location | Cambridgeshire |
| Education | Not Mentioned |
| Salary | Salary negotiable |
| Industry | Not Mentioned |
| Functional Area | Not Mentioned |
| Job Type | Permanent,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 or email , quoting job ref 51322.It is essential that applicants hold entitlement to work in the UK.CLINGEN