CMC Regulatory Affairs Associate Director, Submission Excellence & Project Management

Job description

Are you passionate about the application of science to deliver life‑changing medicines? We are looking for a Chemistry, Manufacturing and Control Regulatory Affairs (CMC RA) Associate Director to join our Respiratory and Immunology team in Biopharm Synthetics. About Chemistry, Manufacturing and Controls Regulatory Affairs Our CMC RA function spans the full product lifecycle and is responsible for the regulatory strategy relating to the development, manufacture, and testing of all AstraZeneca medicines. With our expertise we interpret, anticipate, and shape global Health Authority expectations to build insightful CMC and Device Regulatory Strategies. We are the bridge between our R&D functions, Operations sites, Quality and Global Supply Teams—helping safe, effective medicines reach the right patient at the right time. We manage the timely preparation and delivery of CMC contributions to regulatory submissions across the lifecycle, including Clinical Trial Applications (CTAs), Marketing Authorisation Applications (MAAs), and post‑approval activities. We improve the reliability and value of business‑critical Supply Chain changes by supplying the regulatory context, intelligence, and...