Global Regulatory Affairs Director: Strategy & FDA Leader

Takeda Pharmaceutical Co.; Cambridge (MA); Hybrid; USD 154,000 - 243,000; Full time

Job summary

Takeda Pharmaceutical Co. in Cambridge, MA, seeks an Associate Director to define and lead global regulatory strategies for complex programs, oversee FDA interactions, and guide cross-functional teams toward compliant, timely submissions.

This hybrid role requires an advanced scientific degree and 6+ years in pharma, including regulatory experience; leadership across global teams is essential, along with strong communication and risk mitigation.

Qualifications

• Advanced degree strongly preferred.
• 6+ years of pharmaceutical industry experience including regulatory.
• Preferred experience in reviewing, authoring, or managing regulatory submissions.
• Solid knowledge of drug development process and regulatory requirements (FDA, EU, Canada, ROW).
• Ability to guide teams in regulatory strategy and risk mitigation.

Responsibilities

• Defines strategies and provides tactical guidance to teams for global regulatory success.
• Ensures global regulatory strategies are implemented and maintained.
• Leads FDA meetings and acts as primary contact with health authorities.
• Coordinates with regional leads and vendors for regulatory submissions.
• Oversees regulatory activities and maintains compliance with regulations.
• Demonstrates Takeda leadership behaviors.

Skills

Regulatory strategy

Regulatory submissions

Cross-functional leadership

Communications & negotiation

Education

Advanced degree in a scientific discipline (PharmD/PhD/MD)

Job description

Takeda Pharmaceutical Co. in Cambridge, MA, seeks an Associate Director to define and lead global regulatory strategies for complex programs, oversee FDA interactions, and guide cross-functional teams toward compliant, timely submissions.

This hybrid role requires an advanced scientific degree and 6+ years in pharma, including regulatory experience; leadership across global teams is essential, along with strong communication and risk mitigation.