Senior Director, Global Regulatory Lead – Oncology

Role Summary

Senior Director, Global Regulatory Lead – Oncology leads global regulatory strategy for high-priority oncology programs, guiding cross-functional teams from development through registration and launch readiness. The role sets global regulatory direction, provides expert guidance, and drives late-stage projects to ensure robust strategies across oncology assets. Responsibilities include coordinating with Global Project Teams, leading Global Regulatory Teams, and ensuring timely, high-quality submissions and regulatory decisions.

Responsibilities

• Lead global regulatory strategy for assigned programs across development stages, providing strategic, operational, and tactical regulatory insight on complex oncology projects to accelerate patient access.
• Manage complex or multiple projects within the Oncology portfolio, interfacing with the Global Project Team to support cross-functional objectives.
• Serve as Global Regulatory Lead (GRL) on cross-functional teams for priority programs, providing strategic input and regulatory expertise.
• Lead the Global Regulatory Teams to develop innovative strategies aligned with regulations to achieve business objectives; seek expert advice when needed.
• Operate independently under the direction of a Global Regulatory Portfolio Lead or TA Head; mentor GRT members and expand TA knowledge.
• Align global regulatory strategies with Leadership Team; present regulatory assessments and recommendations to management.
• Keep project teams and stakeholders informed of developments impacting regulatory success; communicate professionally and timely.
• Accountable for US FDA submissions and approvals for projects of responsibility; may serve as primary FDA point of contact.
• Ensure timely, high-quality execution of all submission types, including major submissions (NDA/BLA/MAA).
• Collaborate with Takeda regions to create and execute global regulatory strategies for all projects in area of responsibility.
• Partner with global market access to lead interactions with regulatory/HTA bodies on product-specific value evidence topics.
• Develop/author and execute global regulatory strategies; oversee execution where applicable.
• Monitor regulatory and access environment trends to strengthen development plans and adapt strategies in a timely manner.
• Demonstrate Takeda leadership behaviors; participate in due diligence regulatory assessments for licensing opportunities when applicable.
• Identify and propose solutions for resource gaps in assigned projects.

Qualifications

• BSc/BA in a scientific discipline (strongly preferred); advanced degree (PharmD/PhD/MD) strongly preferred.
• 12+ years in the pharmaceutical industry, including at least 8–10 years in regulatory or related experience.
• Experience reviewing, authoring, or managing components of regulatory submissions including late-stage assets.
• Solid working knowledge of the drug development process and regulatory requirements; knowledge of FDA, EU, Canada, ROW, and post-marketing a plus.
• Ability to interpret complex scientific issues across multiple projects related to regulatory requirements and strategy.
• Ability to interpret scientific data for regulatory strategy and guide teams accordingly.
• Strong oral and written communications, timeline management, negotiation skills, integrity, and adaptability.
• Independent and collaborative regulatory strategy capabilities with broad organizational and global implications; proactively identifies issues and proposes solutions with risk mitigation.
• Ability to work effectively with global teams and align teams toward common objectives.

Education

• BSc/BA in a scientific discipline (required); advanced degree (PharmD/PhD/MD) preferred.