Global Regulatory Lead, Senior Director, GI

5 days ago


Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

Job Summary

We are seeking a Senior Director, Global Regulatory Lead, GI & Inflammation to lead our global regulatory strategy and ensure regulatory compliance across our programs. As a key member of our team, you will define, develop, and implement global regulatory strategies to achieve program objectives and drive business success.

In this role, you will be responsible for leading cross-functional initiatives, managing direct reports, and collaborating with regional counterparts to design and execute global regulatory strategies. You will also communicate with stakeholders, anticipate risks, and develop solutions to mitigate them.

  • Lead global regulatory teams and collaborate with regional counterparts to design and execute global regulatory strategies.
  • Develop and maintain global regulatory strategies to ensure compliance with changing regulatory needs.
  • Communicate with project team colleagues, line management, and stakeholders regarding developments that may impact regulatory success.
  • Anticipate risks and develop solutions to mitigate them, exercising sound judgment and professional communication.

Key Requirements

To succeed in this role, you should have:

  • A Bachelor's Degree in a scientific discipline or advanced degree (PharmD/PhD/MD) preferred.
  • 10+ years of pharmaceutical industry experience, including 8 years of regulatory experience or a combination of 6+ years regulatory and/or related experience.
  • Expert knowledge of drug development processes and regulatory requirements, with a strong understanding of FDA, EU, Canada, ROW, and post-marketing regulations.
  • Strong communication, negotiation, and adaptability skills, with the ability to work well with others in global teams.

About Our Company

Takeda Pharmaceutical is a global company that aims to create better health outcomes for patients worldwide. We believe in fostering a culture of diversity, inclusion, and collaboration, and we offer a competitive compensation package, including U.S. base salary range $205,100 - $322,300, benefits, and opportunities for growth and development.



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