Global Oncology Regulatory Lead — Associate Director

USA - 3316 Takeda Development Center Americas, Inc.; Cambridge (MA); Hybrid; USD 154,000 - 243,000; Full time

Job summary

Takeda in Boston, MA is seeking an Associate Director, Global Regulatory Lead Oncology to define and lead global regulatory strategies for oncology programs, oversee major submissions, and guide cross-functional teams to bring breakthrough treatments to patients worldwide.

You will act as global regulatory lead, coordinate with FDA and other authorities, and partner with market access to align evidence topics. This hybrid role offers a competitive compensation package and growth opportunities.

Qualifications

• Bachelor’s degree in a scientific discipline with strong regulatory emphasis.
• 6+ years in the pharmaceutical industry with regulatory experience.
• Knowledge of FDA, EU, Canada, ROW regulatory requirements and submissions.

Responsibilities

• Define, develop, and lead global regulatory strategies for oncology programs.
• Oversee major submissions and interact with health authorities.
• Coordinate with cross-functional teams to ensure timely regulatory actions.
• Lead regulatory assessment in due diligence for opportunities.
• Mentor junior staff and participate in cross-functional task-forces.

Skills

Regulatory strategy

Cross-functional collaboration

Communication

Timeline management

Negotiation

Team leadership

Education

Bachelor's degree in science

Advanced degree in science

Job description

Takeda in Boston, MA is seeking an Associate Director, Global Regulatory Lead Oncology to define and lead global regulatory strategies for oncology programs, oversee major submissions, and guide cross-functional teams to bring breakthrough treatments to patients worldwide.

You will act as global regulatory lead, coordinate with FDA and other authorities, and partner with market access to align evidence topics. This hybrid role offers a competitive compensation package and growth opportunities.