Director, Global Regulatory Lead - Oncology (Hybrid)

Regulatory Jobs; Boston (MA); Hybrid; USD 177,000 - 278,000; Full time

Job summary

Takeda in Boston, MA, seeks a Director, Global Regulatory Lead Oncology to set global regulatory strategy and lead major submissions for high-impact oncology programs. You will act as global regulatory lead on the GPT and may head the GRT, serving as primary FDA contact for projects.

The role requires 8+ years in pharma regulatory, deep FDA knowledge, and experience with NDA/BLA/MAA filings. This is a hybrid, full-time role with strong collaboration across global teams and leadership

Qualifications

• Bachelor’s Degree in a scientific discipline required.
• A minimum of 8 years of pharmaceutical industry experience, inclusive of regulatory and/or related experience.
• Solid working knowledge of drug development process and regulatory requirements; FDA knowledge required; EU/Canada/ROW a plus.
• Experience in managing major regulatory filing(s) and contributing to regulatory strategies.
• Strong communication, timeline management, and leadership within global teams.

Responsibilities

• Oversee and execute regulatory activities for one or more complex projects.
• Serve as global regulatory lead (GRL) on the global project team for projects of responsibility.
• Lead or co-lead the global regulatory team (GRT) for assigned projects.
• Act as primary FDA contact for projects of responsibility.
• Collaborate with Takeda regions to align global regulatory strategy.
• Monitor regulatory trends and adapt strategies to support development plans.

Education

Bachelor’s Degree

Advanced degree in a scientific discipline

Job description

Takeda in Boston, MA, seeks a Director, Global Regulatory Lead Oncology to set global regulatory strategy and lead major submissions for high-impact oncology programs. You will act as global regulatory lead on the GPT and may head the GRT, serving as primary FDA contact for projects.

The role requires 8+ years in pharma regulatory, deep FDA knowledge, and experience with NDA/BLA/MAA filings. This is a hybrid, full-time role with strong collaboration across global teams and leadership