We redefine the possible everyday
We work closely with colleagues in scientific and commercial teams, supporting the development of new drugs and also maintaining marketing licences worldwide. The main focus of our work is the submission and approval of innovative, effective medicines that make a difference in the lives of patients.
Regulatory Affairs is part of R&D’s Global Medicines Development function. We have 425 people, based at AstraZeneca sites in Mölndal, Sodertalje, Alderley Park and Wilmington, plus a team of regulatory professionals in Osaka, Japan.
Our remit is truly global and cross-functional. The breadth of our work means the team here includes people from all sorts of backgrounds and with varying skill sets. At any time, we will be helping to compile application files and coordinating the contributions from different functions, as well as devising regulatory strategies that will enable us to optimise the value of new and existing products.
More about us
Join us, and you can expect the chance to work with a host of different functions, and to work with alliance partners to secure health authority approvals. You’ll help develop and enhance our capabilities in the areas of drug development, regulatory science and leadership, while taking accountability for the development of regulatory strategies. Your work will help us get approval for our New Drug Applications (NDAs), Supplemental New Drug Applications (SNDAs) and all other regulatory submissions in markets that include the US, Europe and Japan. All the while, you’ll be learning about large molecule regulatory and drug development processes.
The skill groups within Regulatory Affairs include:
- Global & Regional Drug Project Delivery: encompassing Global Regulatory Leaders; Regional Regulatory Affairs Directors; Regulatory Affairs Managers; Global Labelling; Regulatory CMC; and our Submissions Management Group
- Regulatory Policy & Intelligence
- Global Regulatory Operations: including Business Learning & Process Development; Quality Assurance & Compliance; Regulatory Informatics; and Global Electronic Library Governance
