Director, Global Regulatory Affairs – Neuroscience (Hybrid)

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

Job summary

Takeda in Boston, MA seeks a Director of Global Regulatory Affairs, Neuroscience, to lead global regulatory strategies and provide guidance across a Neuroscience TAU portfolio. You will head Global Regulatory Teams and represent regulatory on cross-functional programs, ensuring global regulatory compliance.

The role requires 10+ years in pharma with regulatory experience, strong leadership, and a track record in NDA/BLA submissions, with hybrid work arrangements in Boston.

Qualifications

• Experience developing global regulatory strategies for multiple projects.
• Experience in regulatory submissions (FDA, EU, Canada, ROW) a plus.
• Strong written and verbal communication and timeline management.
• Ability to work with global teams and vendors.

Responsibilities

• Lead Global Regulatory Team (GRT) and sub-groups, guiding global regulatory strategy.
• Maintain oversight of regulatory landscape and advise on risk and opportunities.
• Interpret complex scientific data to inform regulatory strategy.
• Accountable for US FDA submissions and approvals for assigned projects.
• Direct point of contact with FDA and manage meetings.
• Coordinate with regional leads, functions, and vendors for submissions.

Skills

Regulatory strategy

FDA submissions

Cross-functional leadership

Regulatory intelligence

Communication skills

Education

BSc Degree

BA accepted

10+ years regulatory experience

Job description

Takeda in Boston, MA seeks a Director of Global Regulatory Affairs, Neuroscience, to lead global regulatory strategies and provide guidance across a Neuroscience TAU portfolio. You will head Global Regulatory Teams and represent regulatory on cross-functional programs, ensuring global regulatory compliance.

The role requires 10+ years in pharma with regulatory experience, strong leadership, and a track record in NDA/BLA submissions, with hybrid work arrangements in Boston.