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

Regulatory leadership role focusing on developing and executing end-to-end US regulatory strategies for complex rare-disease programs within Alexion/AstraZeneca. Serves as US Strategy Lead for assigned programs, leads US submissions and information packages, coordinates with FDA and Global Regulatory Team, and aligns US and global regulatory plans to maximize registration success. Drives strategic risk assessment, regulatory intelligence, and cross-functional collaboration across commercial, clinical, medical, legal, manufacturing, and portfolio management teams to achieve lifecycle management and timely regulatory decisions. Requires experience in preparing and leading submissions, pre-submission planning, advisory committee activities, and communicating regulatory strategy to senior leadership. In-person/hybrid collaboration at the Gaithersburg, MD site with a minimum 3 days per week in the office, and flexible work arrangements.