Global Regulatory Director - Oncology Strategy

USA - 3316 Takeda Development Center Americas, Inc.; Cambridge (MA); Hybrid; USD 212,000 - 333,000; Full time

Job summary

Takeda seeks a Senior Director, Global Regulatory Lead – Oncology in Boston, MA to steer strategic regulatory direction across development stages for high-impact oncology programs. You will lead cross-functional teams, shape regulatory strategy, and ensure alignment with global and regional stakeholders.

The role requires extensive experience in regulatory affairs, strong communication skills, and the ability to drive submissions with a global perspective.

Qualifications

• BSc/BA Degree required; advanced scientific degree preferred (PharmD/PhD/MD).
• 12+ years in pharmaceutical industry; regulatory experience or mix of regulatory related work.
• Experience reviewing, authoring, or managing regulatory submissions including late-stage assets.

Responsibilities

• Lead global regulatory strategy for assigned oncology programs across development stages.
• Interface with Global Project Team to align objectives and regulatory input.
• Serve as Global Regulatory Lead on cross-functional teams and coordinate with regional teams.

Skills

Regulatory strategy

FDA knowledge

Regulatory submissions

Cross-functional collaboration

Communication skills

Education

BSc/BA Degree

Advanced degree (PharmD/PhD/MD)

Job description

Takeda seeks a Senior Director, Global Regulatory Lead – Oncology in Boston, MA to steer strategic regulatory direction across development stages for high-impact oncology programs. You will lead cross-functional teams, shape regulatory strategy, and ensure alignment with global and regional stakeholders.

The role requires extensive experience in regulatory affairs, strong communication skills, and the ability to drive submissions with a global perspective.