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 launchWork closely with biologics/pharma project teams and regional regulatory representatives to develop regulatory-CMC strategiesParticipate 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 experienceExtensive experience working in CMC regs within the pharma or biologics industryGlobal regulatory submissions experience preferredGood 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