Director, Global Regulatory Lead - Oncology

How you will contribute:
- Oversee and execute regulatory activities for one or multiple complex oncology projects; support regulatory activities for assigned projects.
- Serve as global regulatory lead (GRL) on global project teams; may lead global/regional regulatory sub-teams.
- Act as primary FDA contact; accountable for US FDA submissions and approvals (including timely, high-quality NDA/BLA/MAA submissions).
- Collaborate with Takeda regions to create and execute global regulatory strategy for projects.
- Keep stakeholders apprised of regulatory-impacting developments; participate/lead cross-functional and departmental initiatives.
- Develop/author and execute global regulatory strategies; monitor trends impacting regulatory and access environments.
- May partner with market access on regulatory/health agency/HTA interactions for value evidence topics.
- May lead regulatory assessments for licensing due diligence; identify/propose solutions for resource gaps; may present to senior management.

Minimum Requirements/Qualifications:
- Bachelor’s degree required (scientific discipline strongly preferred); advanced degree strongly preferred.
- 8+ years pharmaceutical industry experience including regulatory and/or related experience.
- Strong drug development and regulatory knowledge; FDA knowledge required (EU/Canada/ROW a plus).
- Experience managing major regulatory filings and contributing to regulatory/development strategy.
- Strong scientific interpretation, communication, negotiation, integrity, adaptability; increasing independence in regulatory strategy; effective collaboration in global teams.

Benefits (explicitly stated): medical/dental/vision, 401(k) + match, disability, life insurance, tuition reimbursement, paid volunteer time off, company holidays, well-being benefits, sick time, paid vacation.

Application instructions: Apply via the “Apply” button.