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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.

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

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.

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

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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