CMC Regulatory Affairs Associate Director

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. 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 expertise, we interpret, anticipate, and shape global Health Authority expectations to build insightful CMC and Device Regulatory Strategies. We are the bridge between R&D functions, Operations sites, Quality and Global Supply Teams—helping safe, effective medicines reach the right patient at the right time. We manage timely preparation and delivery of CMC contributions to regulatory submissions across the lifecycle.

Project manage complex global CMC regulatory programmes ensuring activities and documentation meet high standards, timelines, and business requirements. Lead appropriate CMC teams for submission documentation fit for purpose, considering operational flexibility. Provide support for CMC-related interactions with Health Authorities as needed.

Act as Subject Matter Expert or Process expert, contributing to and advising project teams. Give advice, train and mentor other team members. Contribute to AstraZeneca’s continuous improvement culture by following processes, identifying problems, and implementing improvements.