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Regulatory Executive Senior

Middlesex TW8 9GS   •  Contract/Temporary, Full time


CK Group are recruiting for a Regulatory Executive Senior to join a company in the pharmaceutical industry at their site based in Brentford on a contract basis for 12 months.
Salary:
£392.30 per day PAYE.

The Company:
Our client is a global healthcare company who take on some of the world's biggest healthcare challenges. They provide health benefits to patients and consumers and have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.

The Location:
Brentford is located at the confluence of the rivers Brent and Thames. The area is well severed by public transport from central London, Waterloo station and surrounding areas.

The Role:

  • Preparation of high quality, Chemistry, Manufacturing and Control (CMC) detailed regulatory documents using varied information sources. Liaising closely with other business personnel to ensure accuracy of such records.
  • Working to agreed deadlines and maintaining records to reflecting project status.
  • Responsible for highlighting potential delaying factors promptly to line management and sharing knowledge of regulatory documentation and procedures with others to assist in problem solving. Proactively pursuing process improvement and sharing of best practice.

Your Background:

  • Post Approval CMC experience.
  • CMC authoring experience essential (previous co-ordination role is not sufficient). This should include authoring of module 3 and authoring of CMC variations.
  • Experience responding to manufacturing site change controls and providing regulatory advice and strategies.
  • Detailed proven CMC knowledge and experience for EU and EMAP region.
  • Understands CMC regulations, guidelines, procedures and policies relating registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global CMC applications.

Apply:
For more information or to apply for this Regulatory Executive Senior position, please contact Julie on 01438 870011 or email pharmacontracts@ckagroup.co.uk, quoting job ref 48566.

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

CLINGEN


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

  • Agency: CK Group
  • Contact: Julie Marshall
  • Phone: 01438 723 500
  • Reference: 48566
  • Updated: 20th July 2020
  • Expires: 17th August 2020

CK Group

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