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Senior CMC Regulatory Executive

Brentford, Surrey   •  £0 - £435.72 per day  •  Contract/Temporary, Full time


CK Group are recruiting for a Senior Regulatory CMC Executive to join a company in the healthcare industry at their site based in Brentford on a contract basis for 12 months.

Salary:
Per Day £435.72 PAYE / £569.62 UMB

Company:
Our client is a one of the largest global healthcare companies researching, developing and supplying innovative medicines, vaccines and healthcare products with their global headquarters in the UK. They invest around £1bn in research and development in the UK annually.

Location:
Brentford. This site is the UK headquarters for the company. It houses commercial and business functions as well as scientists and has around 800 staff at the facility.

Rewards:
As a PAYE employee you would be entitled to:

  • Pension
  • Timesheet system
  • Bike schemes

Senior Regulatory CMC Executive Role:

  • Preparation of high quality, CMC detailed regulatory documents using varied information sources.
  • Working to agreed deadlines and maintaining records to reflect project status
  • Responsible for highlighting and sharing knowledge of regulatory documentation and procedures with others.
  • Identifies risks associated with submission data and information packages and ability to propose mitigation actions.
  • May contribute to process improvement and/or regulatory intelligence projects.

Your Background:

  • CMC authoring experience essential (previous co-ordination role is not sufficient). This should include authoring of module 3 and authoring of CMC variations.
  • You will have strong understanding of CMC regulations, guidelines, procedures and policies.
  • Post Approval CMC experience is required.
  • Experience responding to manufacturing site change controls and providing regulatory advice and strategies.
  • You will have the ability to stablish strong relationships and liaise effectively with business sites worldwide

Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 53907 in all correspondence.


You must have the right to work in the UK. Learn more

  • Agency: CK Group
  • Reference: 53907
  • Posted: 21st June 2022
  • Expires: 19th July 2022

CK Group

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