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Associate Director, Global Regulatory Lead, GI

1 month ago

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

Takeda is seeking a highly skilled Associate Director, Global Regulatory Lead, GI & Inflammation to join our team. As a key member of our regulatory affairs department, you will be responsible for defining, developing, and leading global strategies to maximize regulatory success for complex and/or multiple projects.

You will provide strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.

This is a critical role that requires a strong understanding of regulatory requirements and a proven track record of success in leading global regulatory teams.

Key Responsibilities:
  • Define and develop global regulatory strategies to ensure compliance with regulatory requirements
  • Provide strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs
  • Lead global regulatory teams and collaborate cross-functionally to ensure global regulatory compliance
  • Develop and implement risk mitigation strategies to ensure regulatory success
  • Collaborate with cross-functional teams to ensure alignment and effective execution of global regulatory strategies
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
  • Preferred experience in reviewing, authoring, or managing components of regulatory submissions
  • Solid working knowledge of drug development process and regulatory requirements
  • Knowledge of FDA, EU, Canada, ROW and post-marketing a plus
About Takeda:

Takeda is a patient-focused company that is committed to creating a diverse and inclusive workplace. We are a global leader in the pharmaceutical industry, with a strong commitment to innovation and excellence.

We offer a competitive compensation and benefits package, as well as opportunities for professional growth and development.

If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.