Senior Director, Global Regulatory Lead – Oncology

How you will contribute:

• Lead global regulatory strategy for assigned oncology programs across development stages; provide strategic, operational, and tactical regulatory insight to address barriers and accelerate patient access.
• Own complex (potentially multiple) projects within the Oncology TAU; partner with the Global Project Team (GPT) and lead cross-functional priority program teams as global regulatory lead (GRL).
• Lead Global Regulatory Teams (GRT) to develop innovative global regulatory strategies aligned to regulations and business objectives; seek expert support as needed.
• Ensure alignment of global regulatory strategies with leadership; present regulatory assessments and recommendations to management.
• Manage timely, high-quality US FDA submissions and approvals (including NDA/BLA/MAA); may serve as primary FDA point of contact.
• Collaborate across Takeda regions to create and execute global regulatory strategies; partner with market access on value evidence with regulators/health agencies/HTA bodies.
• Develop/author and execute global regulatory strategies; monitor trends impacting regulatory and access environments.
• Demonstrate leadership behaviors; may lead due diligence regulatory assessments; identify/propose solutions for resource gaps.

• BSc/BA in a scientific discipline (strongly preferred).
• Advanced degree (PharmD/PhD/MD) (strongly preferred).
• 12+ years pharma industry experience (including 10+ years regulatory, or 8+ years regulatory/related).
• Experience authoring/reviewing/managing regulatory submissions for late-stage assets.
• Strong knowledge of drug development and regulatory requirements (FDA, EU, Canada, ROW; post-marketing a plus).
• Ability to interpret complex scientific data and advise regulatory strategy; strong communication, negotiation, and timeline management; teamwork and independent regulatory strategy skills.