GI and Inflammation Global Regulatory Leader, Senior Director

3 weeks ago


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

Transformative Opportunities

We are seeking a Senior Director, Global Regulatory Lead, GI & Inflammation to join our team and contribute to transforming patient care through innovative therapies and best-in-class patient support programs. As a key member of our global regulatory team, you will define, develop, and lead 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.

Required Skills

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.

Our Culture

Takeda Pharmaceutical is a patient-focused company that strives to foster a culture of innovation, inclusivity, and collaboration. We offer a comprehensive compensation package, including U.S. base salary range $205,100 - $322,300, benefits, and opportunities for growth and development.

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