Global Regulatory Director, Neuroscience – Strategy & FDA Leadership

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

Benefits offered by this job

Hybrid work model

Job summary

Takeda in Boston, MA is seeking a Director of Global Regulatory Affairs, Neuroscience to lead global regulatory strategy across multiple projects, oversee GRTs, and guide cross‑functional teams toward successful submissions.

You will manage US FDA submissions, including NDA/BLA, serve as primary FDA contact, coordinate with regional leads, vendors, and market access colleagues to align regulatory and pricing strategies, and mentor junior staff.

Qualifications

• BSc or BA with 10+ years in pharma/regulatory context.
• Experience reviewing or managing regulatory submissions.
• Strong knowledge of drug development and regulatory requirements.

Responsibilities

• Lead Global Regulatory Team and cross‑functional groups.
• Define regulatory strategies and ensure global execution.
• Accountable for US FDA submissions and NDA/BLA activities.
• Direct FDA interactions and manage internal regulatory staff.
• Collaborate with global market access and vendors.

Skills

Regulatory strategy

FDA submissions

Cross-functional leadership

Regulatory science

Communication

Risk mitigation

Education

BSc degree

BA accepted

10+ years pharma/regulatory

Job description

Takeda in Boston, MA is seeking a Director of Global Regulatory Affairs, Neuroscience to lead global regulatory strategy across multiple projects, oversee GRTs, and guide cross‑functional teams toward successful submissions.

You will manage US FDA submissions, including NDA/BLA, serve as primary FDA contact, coordinate with regional leads, vendors, and market access colleagues to align regulatory and pricing strategies, and mentor junior staff.