Regulatory Affairs Director

Role: Lead global regulatory strategy and operational execution for oncology products across development and commercialization stages at AstraZeneca. Responsibilities: direct cross-functional teams in major regulatory submissions (NDA/BLA/IND/CTA), develop regional/global strategies for rapid approval with competitive labeling, manage health authority engagements, negotiate regulatory documents, and oversee dossier preparation and lifecycle management. Lead the Global Regulatory Strategy Team, mentor members, and ensure milestones are met while assessing risks and outcomes. Qualifications: Bachelor's in life sciences, pharmacy, biomedical sciences, or related field; minimum 3 years in regulatory affairs within pharma or biotech, with strong experience supporting oncology drug submissions, including INDs, CTAs, NDAs, and BLAs, primarily with FDA interactions. Skills include strategic thinking, cross-functional leadership, regulatory risk assessment, and stakeholder influence, with excellent communication skills. Preferred: advanced degree, experience in hematology, phase 3 development, and contributions to regulatory approvals. High-Value: oncology focus, early and late-stage development, global regulatory strategy, FDA expertise, lifecycle management, and cross-functional leadership in a complex, matrix environment.