Senior Director, Regulatory Affairs (Oncology)

Role: Senior Regulatory Affairs leader responsible for developing and executing global regulatory strategies aligning with asset and corporate goals, ensuring timely, compliant submissions to health authorities. Responsibilities: interact with regulators, conduct regulatory intelligence, guide study and asset teams, oversee preparation and submission of CTAs, INDs, supplements, and other dossiers across regions, review clinical documentation for regulatory compliance, and lead multiple assets or studies. Requirements: Bachelor's degree with 15+ years, Master's with 13+ years, or PhD with 12+ years of relevant experience; extensive knowledge of global regulatory requirements, strategic planning, and leadership skills. Preferred: experience leading regulatory efforts in biopharma, managing cross-functional teams, and familiarity with international regions including Europe and Asia. High-Value: senior leadership in regulatory affairs, global scope, 20% travel, working within biopharma development stages typically spanning early to late-stage clinical trials, with emphasis on compliance, submission quality, and strategic guidance for biologics or small molecules.