Remote Global Regulatory Strategy Lead - Oncology Projects

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

Benefits offered by this job

Hybrid work policy

Global employer recognition

Job summary

Takeda Pharmaceutical Co. in Cambridge, MA, is seeking an Associate Director, Global Regulatory Project Management and Strategic Planning in Oncology.

This remote role partners with the Global Regulatory Lead to drive global strategies and coordinate cross-functional submission teams to meet regulatory milestones. Responsibilities include leading GRT/SWG, overseeing regulatory operations, mentoring RPM colleagues, and driving continuous improvement within a global matrix environment.

Qualifications

• Bachelor's degree required; emphasis in Science preferred.
• Minimum 8 years related experience in Regulatory Project Management, preferably with 4 years in Global Regulatory Affairs.
• Experience on late-stage filings is highly preferred.
• Demonstrated leadership, mentoring, and cross-functional collaboration in a matrix environment.
• Experience with global regulatory submissions and lifecycle management.

Responsibilities

• Lead Global Regulatory Teams (GRT) and cross-functional SWG meetings to oversee regulatory plans and submissions.
• Co-lead and facilitate GPT regulatory goals and operationalize the Global Regulatory Strategy Plan.
• Provide regulatory operational support and oversee vendor deliverables to meet timelines and standards.
• Prepare regulatory reports and metrics for stakeholders; communicate risks and mitigation plans.
• Drive process improvements and lessons learned sessions across programs and RPM/SP groups.

Skills

Leadership

Cross-functional leadership

Project management

Regulatory affairs knowledge

Communication skills

Education

Bachelor's degree

Advanced degree preferred

Tools

MS Project

SharePoint

OnePager

Office Timeline

Job description

Takeda Pharmaceutical Co. in Cambridge, MA, is seeking an Associate Director, Global Regulatory Project Management and Strategic Planning in Oncology.

This remote role partners with the Global Regulatory Lead to drive global strategies and coordinate cross-functional submission teams to meet regulatory milestones. Responsibilities include leading GRT/SWG, overseeing regulatory operations, mentoring RPM colleagues, and driving continuous improvement within a global matrix environment.