Remote Global Regulatory PM & Strategy Lead – Oncology

USA - 3316 Takeda Development Center Americas, Inc.; Cambridge (MA); Remote; USD 154,000 - 243,000; Full time

Job summary

Takeda is seeking an Associate Director, Global Regulatory Project Management and Strategic Planning - Oncology TAU, based remotely in the U.S. Massachusetts/Cambridge area.

This role partners with the Global Regulatory Lead to ensure robust global project plans, cross-functional SWGs, and timely regulatory submissions for late-phase programs. You will lead and coordinate GRT initiatives, align operational plans with GTMs, and drive strategic execution with vendors and external partners.

Qualifications

• Bachelor's degree required; emphasis in science preferred.
• 8+ years related experience in regulatory project management.
• Advanced education or credentialing in regulatory affairs and PM is preferred.
• Proven leadership of high-performance teams in global drug development and regulatory submissions.

Responsibilities

• Lead cross-functional GRT meetings and SWG meetings to deliver regulatory submissions.
• Partner with GRL to operationalize Global Regulatory Strategy Plans.
• Develop integrated regulatory project plans and manage regulatory data workflows.

Skills

Regulatory PM

Global regulatory

Cross-functional leadership

Strategic planning

Education

Bachelor's degree

Tools

MS Project

OnePager

Office Timeline

SharePoint

Job description

Takeda is seeking an Associate Director, Global Regulatory Project Management and Strategic Planning - Oncology TAU, based remotely in the U.S. Massachusetts/Cambridge area.

This role partners with the Global Regulatory Lead to ensure robust global project plans, cross-functional SWGs, and timely regulatory submissions for late-phase programs. You will lead and coordinate GRT initiatives, align operational plans with GTMs, and drive strategic execution with vendors and external partners.