This is a new, key role for Immunocore as it 'comes of age'. We have our first drug in the clinic and a host of new one's hot on it's heels! The Head of CMC Regulatory Affairs will play a key role in both strategy and leadership across a number of divisions internally but also externally with thrid parties and partners.
Based in the UK, this role will report directly in to the VP of Manufacturing and have a dotted line to ur new VP of Regulatory Strategy in the US therefore we're looking for a hands-on, self starter who can work both autonomously as well as part of wider, international team.
- Play a lead role in defining the CMC regulatory strategy associated with all phases of drug development including the coordination and preparation of document package sections/modules for regulatory submissions ensuring compliance with the Food and Drug Administration (FDA), European Union (EMA), and Asia Pacific regulations/interpretations.
- Be the key ‘go-between’ in managing information from/to other departments (including Research, Development, Commercial, and Clinical Affairs) within Immunocore and externally with CDMO’s, regarding the CMC components of regulatory submissions.
- Collaborate with, and influence all internal and external teams to ensure all program related activities meet the highest levels of CMC regulatory compliance.
- Review technical and clinical documentation and recommend changes for labelling, manufacturing, and clinical protocol to ensure regulatory compliance using your significant experience in authoring CMC related regulatory document sections such as investigator’s brochures, Investigational Medicinal Product (IMPD) and IND’s
- Research and analyse regulatory information and determine acceptability of data, procedures, and other product-related documentation presented in support of product registration.
If you don't know who we are already, a few minutes on Google will tell you everything; we're a global leader at the cutting edge of what's possible and we're getting the results! However, those results don't mean anything if they don't save lives. 'Transformational Science that Transforms Lives' is our purpose statement, come and help us bring that to reality.