Regulatory CMC Specalist in Macclesfield
CK Group is recruiting for a Regulatory CMC Specialist to join a company in the Pharmaceutical industry at their site based in Macclesfield on a contract basis for 12 months. The Company: Our client is a global pharmaceutical company with a major presence in the UK. Their purpose is to deliver life-changing medicines and to do this they are completely science-led and like to share this with the scientific, healthcare and business communities within the UK. The Location: This role is located in Macclesfield which is East of Cheshire, on the River Bollin. It is close to the county borders of Greater Manchester to the north, Derbyshire to the east and Staffordshire to the south. It is a gateway to the Peak District and Cheshire Plains, and has breath-taking countryside, parks, rivers, canals, reservoirs and woodland to explore. The Role: This role will work as part of the Regulatory Documentation Team and be focused on documentation for the Chemistry, Manufacturing and Controls (CMC) part of submissions. The CMC Regulatory Documentation supports clinical trials and marketing applications to obtain our commercial manufacturing license. As a CMC Documentation Lead you will be a key member of the project team and have an opportunity to develop a deeper understanding of the regulatory processes and see the full range of Pharmaceutical Development documentation provided to authorities and lead teams. Key Responsibilities: - Accountable within Pharmaceutical Development for the production and delivery of CMC sections of all regulatory documents e.g. marketing and clinical study applications, responses to Health Authority questions and briefing documents. - Define which CMC documents are required. - Prepare for and run the CMC Submission Kick Off meeting. - Lead the delivery team (authors, reviewers, approvers) for the CMC part of submissions. - Lead the review process for all CMC documents, consolidating all comments. - Drive the completion and on-time approval of all CMC documents to submission ready standards. Your Background: To succeed in this role you will have proven experience in a similar role within a pharmaceutical company. You will have been working in a science area with the drug development process involving regulatory documentation using Document Management Systems, e.g. ANGEL. You will also be confident leader and a clear communicator at ease of communicating with senior leaders. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained. CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria. If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45847 in all correspondence.