Global Regulatory Program Director - Strategy & Delivery

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

Job summary

Takeda is seeking a seasoned Regulatory Project Manager in Boston to co-lead Global Regulatory Team meetings and cross-functional SWGs, driving regulatory submissions per strategy. You will align operations with GPT goals, supervise timelines, and oversee vendor-delivered regulatory tasks.

The role requires extensive experience in global drug development regulations, cross-functional leadership, and strong communication skills.

Qualifications

• Bachelor's degree in a related field; advanced degree preferred.
• Significant experience in global drug development regulations and regulatory submissions.
• Experience leading cross-functional teams and mentoring colleagues.
• eCTD experience and regulatory operations knowledge are required.

Responsibilities

• Co-lead and facilitate Global Regulatory Team (GRT) meetings and cross-functional SWG meetings.
• Align operational plans with Global Product Team (GPT) regulatory goals and execute Global Regulatory Strategy Plan.
• Develop and maintain integrated regulatory project plans and SWG plans; ensure timelines and vendor deliverables meet standards.
• Provide regulatory operational support and guidance; manage regulatory document workflows and data tracking.

Education

Bachelor's degree

Advanced degree preferred

Regulatory affairs certification preferred

Tools

Planisware

Microsoft Project

OnePager

Office Timeline

SharePoint

Job description

Takeda is seeking a seasoned Regulatory Project Manager in Boston to co-lead Global Regulatory Team meetings and cross-functional SWGs, driving regulatory submissions per strategy. You will align operations with GPT goals, supervise timelines, and oversee vendor-delivered regulatory tasks.

The role requires extensive experience in global drug development regulations, cross-functional leadership, and strong communication skills.