Remote Global Regulatory PM & Strategy Lead, Oncology

Takeda; Cambridge (MA); Hybrid; 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 USA. The role partners with the Global Regulatory Lead to plan, coordinate, and deliver regulatory submissions across diverse programs, ensuring compliance and efficiency.

Ideal candidate will bring 8+ years in regulatory project management, strong leadership, and experience with global submissions, timelines, and cross-functional collaboration within a

Qualifications

• Bachelor's degree required; emphasis in Science preferred
• Advanced degree preferred
• Ideal candidate has a minimum of 8 yrs related experience in Regulatory Project Management
• Experience with late-stage filings and global regulatory submissions desired
• Strong leadership, communication and cross-functional collaboration skills

Responsibilities

• Lead cross-functional submission working groups to deliver regulatory submissions.
• Co-lead and facilitate Global Regulatory Team meetings to align regulatory strategy.
• Provide regulatory operational support and oversee vendors for assigned programs.
• Deliver reports and metrics on milestone status, risks and mitigations.
• Drive continuous improvement in regulatory processes and governance.

Skills

Regulatory project management

Global regulatory affairs

Cross-functional leadership

Strategic planning

Regulatory submissions

Vendor management

Regulatory operations

Leadership presence

Project leadership

Communication

Education

Bachelor's degree

Advanced degree preferred

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 USA. The role partners with the Global Regulatory Lead to plan, coordinate, and deliver regulatory submissions across diverse programs, ensuring compliance and efficiency.

Ideal candidate will bring 8+ years in regulatory project management, strong leadership, and experience with global submissions, timelines, and cross-functional collaboration within a