Global Regulatory Lead, Oncology — Hybrid Role

Regulatory Jobs; Boston (MA); Hybrid; USD 154,000 - 243,000; Full time

Job summary

Takeda is seeking an Associate Director, Global Regulatory Lead Oncology in Boston to define and lead global regulatory strategies for oncology programs and oversee major submissions. You will guide cross-functional teams to bring breakthrough therapies to patients worldwide and serve as the primary FDA contact for your projects.

The role requires 6+ years in pharma regulatory, strong communication skills, and experience with global submissions. The position is hybrid and based in Boston, MA.

Qualifications

• Bachelor’s Degree in a scientific discipline; an advanced degree is strongly preferred.
• 6+ years of pharmaceutical industry experience including regulatory and/or related work.
• Solid working knowledge of drug development and regulatory requirements (FDA, EU, Canada, ROW; post-marketing a plus).
• Experience in reviewing, authoring, or managing components of regulatory submissions is preferred.
• Strong oral and written communication, timeline management, and cross-functional collaboration.

Responsibilities

• Define, develop, and lead global regulatory strategies for oncology programs.
• May lead Global Regulatory Teams (GRTs) for assigned projects.
• Serve as global/regional regulatory lead and primary FDA contact for projects of responsibility.
• Oversee US FDA submissions and approvals.
• Collaborate with Takeda regions to ensure a global regulatory strategy is created and executed.
• Lead regulatory due diligence discussions and interactions with health authorities as applicable.

Skills

Regulatory strategy

FDA knowledge

Regulatory submissions

Cross-functional leadership

Education

Bachelor’s degree (science)

Advanced degree preferred

Job description

Takeda is seeking an Associate Director, Global Regulatory Lead Oncology in Boston to define and lead global regulatory strategies for oncology programs and oversee major submissions. You will guide cross-functional teams to bring breakthrough therapies to patients worldwide and serve as the primary FDA contact for your projects.

The role requires 6+ years in pharma regulatory, strong communication skills, and experience with global submissions. The position is hybrid and based in Boston, MA.