Director of Global Regulatory Affairs

8 hours ago


Boston, Massachusetts, United States Takeda Pharmaceutical Full time

We are seeking an experienced professional to join our team as an Associate Director, Global Regulatory Lead, GI & Inflammation. This role will be responsible for defining, developing, and leading global strategies to maximize regulatory success for complex projects.

About Takeda Pharmaceutical:

Takeda is a world-class R&D organization that unlocks innovation and delivers transformative therapies to patients worldwide. We focus on four therapeutic areas and other targeted investments, pushing the boundaries of what's possible to bring life-changing therapies to patients globally.

Responsibilities:
  • Provide strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.
  • Lead the Global Regulatory Teams (GRTs) and represent GRTs at project team meetings.
  • Accountable for all US FDA submissions and approvals of project(s) of responsibility.
Qualifications:
  • Bachelor's Degree, scientific discipline strongly preferred.
  • Advanced degree in a scientific discipline (Ph.D./M.D.) strongly preferred.
  • 6+ years of pharmaceutical industry experience.

Salary Range: $149,100 - $234,300 per year

This role offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We value diversity and equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, or other protected characteristics.



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