Job Description

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. Chemistry, Manufacturing, and Controls Regulatory Affairs (CMC RA) Our Chemistry, Manufacturing, and Control (CMC) Regulatory Affairs function spans across the product lifecycle and is responsible for the regulatory strategy relating to the development, manufacture and testing of all of our medicines. With our expertise we interpret, anticipate and craft 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 in helping safe, effective medicines reach the right patient at the right times. We manage the timely preparation and delivery of CMC contributions to the regulatory submissions linked to medicinal products throughout the product lifecycle; including Clinical Trial Applications (CTAs), Marketing Authorisation Applications (MAAs) and all post approval activities improving the reliability and value of business critical Supply Chain changes to the AZ organization by supplying the regulatory context, intelligence and mentorship for robust approval and change management.