Regulatory Affairs Director

Role: Regulatory Affairs Director leading regulatory strategy and submissions for AstraZeneca's Infectious Disease portfolio, focusing on vaccines and anti-infectives. Responsibilities: develop and implement global/regional regulatory strategies, oversee major submissions (BLA/MAA/IND/CTA), lead cross-functional teams, manage regulatory milestones, and ensure effective collaboration across functions. Requirements: Bachelor's in life sciences, 7+ years of regulatory drug development, experience with global approvals, knowledge of regulatory procedures and legislation, proven leadership and project management skills, excellent communication. Preferred: advanced degree, vaccine or anti-infective experience, global regulatory lead experience, FDA/EMA interactions, and due diligence expertise. HighValue: infectious disease therapeutics, vaccines, anti-infectives, global regulatory submissions, cross-functional leadership, experience with major regulatory agencies. WorkSetup: hybrid model with in-person collaboration, flexible working options.