Regulatory Affairs Director, Digital Projects

Role: Regulatory Affairs Director, Digital Projects within AstraZeneca's Respiratory and Immunology portfolio, leading AI and automation initiatives to optimize regulatory processes and data foundations. Responsibilities: develop and execute digital strategies, partner with cross-functional teams (IT, Regulatory Systems, enterprise AI), promote AI adoption through training, establish standard workflows, and monitor performance metrics. Qualifications: 10+ years in biopharmaceuticals or related fields, with expertise in data science, analytics, and regulatory affairs or working with Health Authorities (FDA, EMA). Technical skills include developing data dashboards, using low/no code platforms, scripting (Python, SQL, VBA), and experience with AI tools like Generative AI. Preferred: programming proficiency, familiarity with regulatory datasets, advanced analytics, and machine learning. High-Value: focus on digital transformation in regulatory processes, AI and automation deployment, and cross-sector collaboration in R&I; location at AZ Gaithersburg. The role involves strategic leadership, technical implementation, and stakeholder communication to enhance regulatory efficiency and compliance in drug development.