Associate Director, Global Regulatory Lead, GI

21 hours ago


Boston, Massachusetts, United States Takeda Full time
About the Role

Takeda is a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. As an Associate Director, Global Regulatory Lead, GI & Inflammation, you will define, develop, and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects.

Key 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 applicable sub-working groups, such as the Label Working Group, and represents GRTs at project team meetings.
  • Define strategies and provide tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible.
Requirements
  • Bachelor's Degree, scientific discipline strongly preferred
  • Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred
  • 6+ years of pharmaceutical industry experience, inclusive of 4 years of regulatory experience or combination of 6+ years regulatory and/or related experience
About Takeda

Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.



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