Associate Director Regulatory Affairs

Associate Director Regulatory Affairs - CMC Advanced Resource Managers are looking for an Associate Director of Regulatory Affairs - CMC to join our client who is a leading Biotech business through a CRO. This role will be solely working with one of their main partners focusing on driving and leading regulatory CMC strategy. You will provide innovative solutions including global regulatory therapeutic area expertise, strategic regulatory intelligence and guidance for product development from preclinical through registration and product optimization although the team have a preference for someone to have strong post-approval experience over pre-approval. You will be leading the development and execution of CMC regulatory strategies for biological products in the EMEA region. Serve as the subject matter expert on biologics, providing CMC regulatory guidance for the preparation of regulatory submissions to the EMA and regional agencies. Oversee the preparation, review, and submission of CMC sections (Module 3) specific to biological products, in regulatory filings such as MAA and variations. Post-Approval Compliance and Life Cycle Management : Perform change control impact assessment for CMC changes Lead the CMC regulatory management and submission planning of post-approval changes, including manufacturing process changes, site transfers, and formulation updates for biological products Ensure continuous compliance with regulatory requirements throughout the lifecycle of the biological product, managing variations and renewals. This role is a permanent full time position and will offer a competitive salary alongside an extensive benefits package. If you are interested in hearing more please email me on [email protected]