Executive Director, Regulatory Affairs – Global Regulatory Leader

Role: Executive Director of Regulatory Affairs - Global Regulatory Leader, overseeing regulatory strategies for oncology therapeutics from development through post-marketing. Responsibilities: independently lead global regulatory planning for IND/CTA approvals, support subsequent BLA/MAA submissions, represent regulatory in collaborations, guide cross-functional teams on regulatory content and strategy, develop tumor landscape assessments, advise on laws and standards, lead risk mitigation, and oversee labeling strategies. Qualifications: Bachelor's in life sciences with 15+ years in pharma/biotech regulatory activities, including lead roles in US and at least two major regions (EU, Japan, China); extensive experience with marketing/license applications (BLA, NDA, MAA) in late-stage development; proven global regulatory strategy expertise; leadership and project management skills; experience interfacing with regulatory authorities. Preferred skills include advanced degrees (Masters/Doctorate), strong communication, negotiation, and cross-functional collaboration abilities. High-Value: Oncology (NSCLC, CRC), Phase 3 clinical trials, global regulatory approvals, late-stage development, strategic leadership, and direct partner engagement. WorkSetup: remote with up to 5% travel.