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CMC Specialist

Hertfordshire   •  Contract/Temporary, Part time


CK Group are recruiting for a CMC Specialist to join a global medical technology company in the pharmaceutical industry at their site based in Watford on a contract basis until the end of December 2021. This is a part time position of 20 hours per week.

Salary:
Up to £54.02ph PAYE. This role has been assessed as inside IR35

CMC Specialist Role:
? Lead regulatory submission teams on biologics/pharma projects to meet the Company\'s product launch
? Work closely with biologics/pharma project teams and regional regulatory representatives to develop regulatory-CMC strategies
? Participate in change control teams for CMC changes.
? Assesses the regulatory impact of changes in biologics/pharma product specifications, manufacturing process, labelling, and other changes to ensure compliance with EU requirements, including compliance with cGMP, GDP and GCP requirements

Your Background:
? Bachelor\'s degree required, in the area of chemistry, biology or a closely related science discipline or equivalent working experience
? Extensive experience working in CMC regs within the pharma or biologics industry
? Global regulatory submissions experience preferred
? Good working knowledge of cGMP, GDP, GDocP and other regulatory requirements

Company:
Our client takes a pioneering approach to the design of advanced medical products and services, holding lead positions in Orthopaedics Reconstruction, Wound Management and Sports Medicine.

Location:
This CMC Specialist role will be home based with travel to our clients site in Watford, Hertfordshire for meetings

Apply:
Entitlement to work in the UK is essential. Please quote reference 50168.


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

  • Agency: CK Group
  • Contact: Lucy Stendall
  • Phone: 01246 457733
  • Reference: 50168
  • Posted: 18th March 2021
  • Expires: 15th April 2021

CK Group

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