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.