Associate Director, Regulatory Affairs US Lead, Regulatory Science & Execution

Associate Director, US Lead for Regulatory Science & Execution with AstraZeneca’s Alexion division will develop, implement, and maintain regulatory strategies for assigned programs to achieve successful registration and lifecycle management. The role drives end-to-end regulatory strategy across all development stages, leads US submissions as part of the Global Regulatory Team, and coordinates with FDA and cross-functional partners to align US and global regulatory plans. The position requires strategic advisory capabilities, risk analysis, and clear communication to senior leadership and regulatory authorities. The role is based in Gaithersburg, MD with a hybrid in-office schedule (minimum three days per week in the office) and involves collaboration across commercial, research, clinical development, medical affairs, manufacturing, quality, and other functions. The role supports development of forward-looking regulatory strategies, anticipates regulatory challenges, and ensures integration into global strategy while maintaining ethics and transparency. The posting notes a base pay range of $135,624.80 - $203,437.20 USD annually, with eligible benefits and compensation programs.