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Regulatory Affairs Manager

Cambridgeshire CB4 0WD   •  Contract/Temporary, Full time

CK Group are recruiting for a Regulatory Affairs Manager to join a biopharmaceutical company either from home or at their site based in Cambridge on a contract basis for 12 months.
Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.

This Regulatory Affairs Manager role can be remote or based at our clients site in Cambridge.


Regulatory Affairs Manager Role:

  • Ensure that the company acquires and maintains all the required approvals in order to support clinical trials for investigational medicinal products as well as to market approved medicinal products.
  • Ensure timely regulatory compliance with above approvals.
  • As requested this role may provide management and leadership by supervising one or more other regional regulatory leads and/or support staff (dependent on grade).

Your Background:

  • Understanding of Regulatory principles.
  • Working with policies, procedures and SOPs.
  • Knowledge of relevant legislation and regulations relating to medicinal products.
  • Awareness of the regulatory procedures in region for MAs, CTAs, post approval changes and amendments, extensions and renewals.
  • Knowledge of drug development.
  • Cultural awareness and sensitivity to achieve results across both regional country and International borders.

For more information or to apply for this Regulatory Affairs Manager position, please contact CK Group, quoting job ref 48390.

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

You must be eligible to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Julie Marshall
  • Phone: 01438 723 500
  • Reference: 48390
  • Posted: 9th October 2020
  • Expires: 6th November 2020

CK Group

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