Global Regulatory Strategy & Program Management Lead

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

Job summary

Takeda Pharmaceutical Co. in Boston, MA is seeking a senior regulatory/PM leader to co-drive global submissions and cross-functional programs. You will partner with the Global Regulatory Lead to align regulatory strategies with product teams and business units, while managing timelines and stakeholders.

You will drive integrated regulatory plans, oversee outsourced deliverables, and mentor teams to ensure high-quality submissions and continuous process improvements across global programs.

Qualifications

• Bachelor's degree required; science emphasis preferred.
• 8+ years related experience with 4+ years in regulatory.
• Experience in global drug development regulations and lifecycle management.
• eCTD experience required; ability to lead high-performance teams.
• Strong communication and leadership in cross-functional settings.

Responsibilities

• Co-lead and facilitate Global Regulatory Team meetings and SWG meetings.
• Align regulatory strategy with Global Product Team goals and TAU/BU asset strategies.
• Develop integrated regulatory project plans and track milestones.
• Provide regulatory operational support and ensure timely deliverables from vendors.
• Prepare reports on milestone status, risks, and mitigation plans.
• Lead continuous improvement and share regulatory project management knowledge.

Skills

Leadership

Regulatory knowledge

Cross-functional collaboration

Project management

Strategic thinking

Problem solving

Education

Bachelor's degree

Advanced degree preferred

Tools

Planisware

Microsoft Project

OnePager

Office Timeline

SharePoint

Job description

Takeda Pharmaceutical Co. in Boston, MA is seeking a senior regulatory/PM leader to co-drive global submissions and cross-functional programs. You will partner with the Global Regulatory Lead to align regulatory strategies with product teams and business units, while managing timelines and stakeholders.

You will drive integrated regulatory plans, oversee outsourced deliverables, and mentor teams to ensure high-quality submissions and continuous process improvements across global programs.