Senior Regulatory CMC Executive

DescriptionCK 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.

Per Day £435.72 PAYE / £569.62 UMB
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.
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.

As a PAYE employee you would be entitled to:
Weekly/monthly payroll options
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
It is essential that applicants hold entitlement to work in the UK
Please quote job reference 53867 in all correspondence
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Salary Min0Salary Max435Contract TypeContractSalary TypeDayAdded22dID905216