Senior Regulatory Affairs Director

Role: Senior Regulatory Affairs Director responsible for developing and implementing global regulatory strategies for complex oncology products, ensuring rapid approval and advantageous labeling. Responsibilities include leading global dossier construction, regulatory risk management, guiding cross-functional Regulatory Sub-teams, and managing product lifecycle activities such as compliance and maintenance. The role requires strategic leadership, deep understanding of global regulatory science, and experience with high-profile, complex or biologic oncology programs. Qualifications: Bachelor's in a scientific or regulatory field, 10+ years in drug/biologic development, proven success in global regulatory approvals, and leadership in cross-functional teams. Preferred: Master's or PhD, experience with radio-conjugates, FDA/CHMP interactions, and oncology (small molecules/biologics). The position involves stakeholder collaboration across regions, managing regulatory milestones, and influencing regulatory strategies. Work setup: not specified, but involves leadership of global teams and cross-regional coordination.