Regulatory Affairs Manager

  • Salary: £44 per hour PAYE DOE
  • REF Number: 00048390
  • Consultant: Julie Marshall
  • Contact: 01438 870011
  • Date Published: 16.06.2020
  • Sector: Non-Specific
  • Location: Cambridge, South East
  • Discipline: Regulatory Affairs

CK Group are recruiting for a Regulatory Affairs Manager to join a biopharmaceutical company at their site based in Cambridge on a on a contract basis for 12 months.

Company: 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.

Location: This Regulatory Affairs Manager role will be based at our clients site in Cambridge.

Salary: Hourly rate of £44 per hour PAYE dependant on experience.

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 SOP?s 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.

Apply: For more information or to apply for this Regulatory Affairs Manager position, please contact Julie on 01438 870011 or email pharmacontracts@ckagroup.co.uk, quoting job ref 48390.

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

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