Job Description

We are looking for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs Managers to join our organisation on a 12 month fixed term contract and work in the development space, from First Time in Man to initial Marketing Authorisation Applications. About AstraZeneca 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 (CMC) Our Chemistry, Manufacturing, and Controls (CMC) Regulatory function spans across the product lifecycle and are responsible for the regulatory strategy relating to the development, manufacture and testing of all of our 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 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 commercial lifecycle; including Clinical Trial Applications (CTAs), Marketing Authoring Applications (MAAs) and all post approval activities improving the value of business critical Supply Chain changes to the AZ organization by supplying the regulatory context, intelligence and guidance required to advise the development of robust plans for change initiatives. What you’ll do Being a CMC RA Manager, means that you will effectively manage the production of Chemistry, Manufacturing and Control (CMC) documentation for designated product ranges to deliver the needs of both the AZ business and the customer. You will project manage global CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards across the product lifecycle. As a CMC RA Manager you will also contribute and own the regulatory CMC components of business-related projects having effective levels of interactive communication with collaborators and project team members to ensure that relevant timelines and regulatory commitments are communicated. The accountabilities also include responsibility for change management as assigned and to ensure the learning from own projects are shared with other co-workers/within the function.