Regulatory Affairs Director - Oncology

Role: Regulatory Affairs Director focused on US regulatory strategy for oncology medicines, supporting development, submissions, approvals, and lifecycle management. Responsibilities: lead regulatory submissions (INDs, NDAs, BLAs), develop regional strategies for rapid approvals and competitive labeling, drive agency engagement, manage cross-functional US Oncology Regulatory Strategy teams, and influence global product direction through regulatory expertise. Requirements: Bachelor's in Life Sciences or related field; extensive experience in Regulatory Affairs or drug development within pharma/biotech; proven track record with regulatory submissions, agency interactions, and cross-functional leadership; exceptional communication and strategic skills; experience in a global matrix environment. Preferred: oncology regulatory experience, advanced degrees (MS, PharmD, PhD, MD), involvement in pivotal milestones and negotiations. High-Value: oncology, US market, regulatory submissions, global stakeholder engagement, and leadership in complex programs. Work setup: not specified, but role involves significant interaction with health authorities and internal teams, and influencing regulatory strategies.