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Global Regulatory Affairs Leader

4 weeks ago

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

Takeda Pharmaceutical is seeking a highly skilled Associate Director to lead our Global Regulatory Affairs team. As a key member of our organization, you will be responsible for defining and developing global strategies to maximize regulatory success for complex and 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 leadership role that requires strong communication and negotiation skills, as well as the ability to work collaboratively with cross-functional teams.

Key Responsibilities:
  • Lead the Global Regulatory Team and represent the team at project meetings
  • Define strategies and provide tactical guidance to teams to ensure global regulatory compliance
  • Collaborate with cross-functional teams to ensure the global regulatory strategy is updated and executed
  • Proactively anticipate risks and develop solutions to identified risks
  • Accountable for all US FDA submissions and approvals
Requirements:
  • Bachelor's Degree in a relevant field (preferably a BSc)
  • 8+ years of pharmaceutical industry experience, including 6 years of regulatory experience
  • Strong working knowledge of drug development process and regulatory requirements
  • Ability to understand and interpret complex scientific issues and data
  • Excellent communication and negotiation skills
About Takeda:

Takeda Pharmaceutical is a patient-focused company that is committed to creating a diverse and inclusive workplace. We offer a stimulating career with opportunities for growth and development, as well as a competitive compensation and benefits package.

We are proud to be a Global Top Employer and are committed to making a positive impact on the lives of patients around the world.