Associate Director, Global Regulatory Project Management and Strategic Planning - Oncology

Role: Associate Director, Global Regulatory Project Management and Strategic Planning in Oncology at Takeda, remotely based. Responsibilities: partner with the Global Regulatory Lead to develop and execute global regulatory project plans, lead cross-functional submission teams to ensure successful regulatory filings, oversee operational support activities, and drive continuous process improvements. Manage relationships with vendors and internal stakeholders, prepare reports on regulatory milestones, and escalate critical issues. Qualifications: Bachelor's degree in Science or related field; 8+ years of regulatory project management experience, including global drug development and late-stage filings; demonstrated leadership in cross-functional teams; expertise in regulatory submissions, eCTD filings, and compliance, particularly within oncology. Preferred: advanced degrees or certifications in regulatory affairs or project management; experience with global regulatory strategies and post-market activities. HighValue: oncology, late-stage development, global regulatory submissions, cross-functional leadership, vendor management, regulatory strategy planning, and operational support. WorkSetup: remote in the USA, with hybrid options.