Associate Director, Regulatory Strategy

Role: Associate Director, Regulatory Strategy at Syndax Pharmaceuticals, responsible for developing and executing global regulatory plans for oncology or immunology assets throughout all development phases. Objectives include securing investigational and marketing approvals, leading the Regulatory Sub team, and ensuring compliance with global regulatory standards. Responsibilities encompass preparing and leading submissions (INDs, marketing applications), serving as the primary regulatory contact with authorities like the FDA, and managing relationships with CROs. The role also involves strategic risk mitigation, regulatory trend analysis, and process improvement. Qualifications: Bachelor's degree in a scientific discipline; advanced degree (PharmD, Ph.D., MD) preferred; 8+ years in pharma/biotech, including 5+ years in Regulatory Affairs leadership with global experience. Experience in drug development within oncology, immunology, or rare diseases, and direct engagement with health authorities in major markets are required. Knowledge of global regulatory guidance, submission processes, and cross-functional partnering are essential. Desired skills include strong project management, communication, and problem-solving capabilities. The role is remote, based in New York, with an indicative salary range of $195K-$220K, and involves working across multiple development phases and international regulatory landscapes.