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Regulatory Affairs Manager

Middlesex   •  Contract/Temporary, Full time

CK Group are recruiting for a Regulatory Affairs Manager to join a biopharmaceutical company at their site based in Uxbridge on a contract basis for 6 months.

Up to £42.59 ph PAYE

Regulatory Affairs Manager Role:
? Act as a contact with relevant regulatory agencies in fulfilling local obligations by product assignment Document and communicate details and outcomes of regulatory agency interactions to GRT and relevant sr. management
? Implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
? Provides content guidance for regional regulatory documents and meetings in accordance with strategy
? Manages in the development of the regional product label by collaborating with the Labeling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.

Your Background: (As a minimum, you must have a background in CTA and EU)
? 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, PIPS, 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 would be advantageous but is not essential as training can be given.

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 will be based at our clients site in Uxbridge, Greater London.

Entitlement to work in the UK is essential. Please quote reference 50638.

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

  • Agency: CK Group
  • Contact: Dennis Beltman
  • Phone: 01438 870027
  • Reference: 50638
  • Updated: 9th September 2021
  • Expires: 7th October 2021

CK Group

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