Global Regulatory Lead, Oncology — Strategy & Submissions

USA - 3316 Takeda Development Center Americas, Inc.; Cambridge (MA); Hybrid; USD 177,000 - 278,000; Full time

Job summary

Takeda is seeking a Director, Global Regulatory Lead Oncology to set global regulatory strategy and lead major submissions for high-impact oncology programs. You will serve as GRL on GPTs, coordinate with global teams, and ensure FDA submissions and other major filings are executed on time with high quality.

The role requires 8+ years in pharma regulatory affairs, strong FDA knowledge, and ability to influence across global teams.

Qualifications

• Bachelor’s degree in a scientific discipline required; advanced degree preferred.
• Minimum 8 years of pharmaceutical industry regulatory experience.
• Strong knowledge of FDA regulations; EU/Canada/ROW knowledge a plus.
• Experience leading major regulatory filings and strategy development.
• Excellent written and oral communication, leadership, and teamwork.

Responsibilities

• Oversee and execute regulatory activities for one or more complex projects.
• Serve as global regulatory lead on project teams.
• Lead or participate in global regulatory sub-teams and interactions with regulators.
• Ensure timely, high-quality submission planning and execution (NDA/BLA/MAA).
• Develop and implement global regulatory strategies for complex programs.

Skills

Regulatory strategy

FDA knowledge

Cross-functional leadership

Project management

Communication

Global regulatory

Education

Bachelor's degree in science

Advanced degree preferred

Tools

N/A

Job description

Takeda is seeking a Director, Global Regulatory Lead Oncology to set global regulatory strategy and lead major submissions for high-impact oncology programs. You will serve as GRL on GPTs, coordinate with global teams, and ensure FDA submissions and other major filings are executed on time with high quality.

The role requires 8+ years in pharma regulatory affairs, strong FDA knowledge, and ability to influence across global teams.