Global Regulatory Director — GI & Inflammation

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

Benefits offered by this job

Hybrid work policy

Job summary

Takeda in Boston, MA seeks a Director of Regulatory Strategy to define and lead global regulatory strategies for complex programs, collaborating cross-functionally to ensure compliance and timely submissions. The role leads GRTs, coordinates health authority interactions, and mentors regulatory staff.

The position requires 8+ years in pharma regulatory roles, with strong knowledge of FDA and international regulations, plus excellent communication and leadership skills. Hybrid work arrangement.

Qualifications

• 8+ years of pharmaceutical industry experience.
• Strong knowledge of FDA, EU, Canada and ROW regulatory requirements.
• Experience reviewing, authoring, or managing components of regulatory submissions.
• Excellent written and oral communication, ability to manage timelines and negotiate clearly.

Responsibilities

• Lead Global Regulatory Teams (GRTs) and sub-working groups.
• Define regulatory strategies and guidance for projects across regions.
• Coordinate regulatory submissions and interactions with health authorities including FDA meetings.
• Mentor junior staff and manage direct reports.

Skills

Regulatory leadership

Regulatory strategy

FDA meetings

Regulatory submissions

Cross-functional teamwork

Education

Bachelor's degree

Advanced degree preferred

Job description

Takeda in Boston, MA seeks a Director of Regulatory Strategy to define and lead global regulatory strategies for complex programs, collaborating cross-functionally to ensure compliance and timely submissions. The role leads GRTs, coordinates health authority interactions, and mentors regulatory staff.

The position requires 8+ years in pharma regulatory roles, with strong knowledge of FDA and international regulations, plus excellent communication and leadership skills. Hybrid work arrangement.