Senior Regulatory Affairs Manager – Nephrology and Inflammation, based in Cambridge and Uxbridge, UK

Our client, a leading biotechnology company, is currently looking for an experienced Senior Regulatory Affairs Manager to join their Nephrology and Inflammation Therapeutic Area.

As a Senior Regulatory Affairs manager, your role will be to develop and implement regulatory strategies to expedite global drug development and registration and to manage the execution of regional strategies and regulatory communications and submissions. You will assist in providing expertise on regional regulatory requirements and precedence to interdepartmental teams.

Further key activities of this Senior Regulatory Affairs Manager job will include:

  • Participate through the Global Regulatory Team in the development of product label and core data sheet.
  • Respond to requests from the Global development team and functional areas.
  • Advocate and actively support regulatory compliance.
  • Help to develop regional regulatory strategy for integration into the Global Regulatory Plan.
  • Develop TA expertise.
  • Help resolve any problems on the critical path to regional registration in concert with global registration strategy.

The ideal candidate for this Senior Regulatory Affairs Manager job will be qualified to a minimum Bachelors degree. You will have in-depth experience of Regulatory Affairs Research Development or related area in the Biotech/Pharmaceutical industry, along with experience in inflammation, drug development and CMC knowledge. Line management experience is also desirable.

How to Apply

If you would like to hear more about this Senior Regulatory Affairs Manager job, please contact Meera Pattni on 01438 743047 or email mpattni@ckclinical.co.uk.

Alternatively, click here to apply for this Senior Regulatory Affairs Manager job now.

 

About CK Clinical

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