Global Regulatory Strategy Director

Regulatory Jobs; Boston (MA); Hybrid; USD 177,000 - 278,000; Full time

Job summary

Takeda is seeking a Director of Global Regulatory Strategy in Boston, MA to lead complex regulatory programs and drive global regulatory strategies aligned with program objectives. The role requires deep FDA submission experience, cross-functional leadership, and the ability to navigate global regulatory environments.

You will mentor teams, collaborate with regional leads, and ensure timely regulatory decisions while maintaining compliance and contributing to Takeda’s strategic initiatives.

Qualifications

• Bachelor’s Degree, scientific discipline strongly preferred.
• Advanced degree strongly preferred.
• 8+ years of pharmaceutical industry experience with regulatory experience or a combination of regulatory and related experience.

Responsibilities

• Defines, develops and leads global regulatory strategies to maximize success across complex projects.
• Leads Global Regulatory Teams and cross-functional groups, ensuring strategy execution.
• Accountable for US FDA submissions and approvals; leads submission types.
• Mentors direct reports and collaborates with regional counterparts to align regulatory plans.
• Identifies regulatory risks and crafts proactive mitigation strategies.

Skills

Regulatory strategy

Cross-functional leadership

Regulatory submissions

Communication

Leadership

Education

Bachelor’s Degree in a scientific discipline

Advanced degree (PharmD/PhD/MD)

Job description

Takeda is seeking a Director of Global Regulatory Strategy in Boston, MA to lead complex regulatory programs and drive global regulatory strategies aligned with program objectives. The role requires deep FDA submission experience, cross-functional leadership, and the ability to navigate global regulatory environments.

You will mentor teams, collaborate with regional leads, and ensure timely regulatory decisions while maintaining compliance and contributing to Takeda’s strategic initiatives.