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Senior Director, Global Regulatory Lead, GI

1 month ago

Boston, Massachusetts, United States Takeda Pharmaceutical Full time

About the Role:

Takeda is a patient-focused company that is transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. We are seeking a Senior Director, Global Regulatory Lead, GI to join our team.

This role will be responsible for defining, developing, and leading global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. The successful candidate 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.

Key Responsibilities:

  • Define strategies and provide tactical guidance to teams and collaborate cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance.
  • Lead the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represent GRTs at project team meetings.
  • Ensure global regulatory strategies defined within the GRT are effectively implemented and maintained in line with changing regulatory and business needs and anticipate such changes to lead adaptations to regulatory strategy.
  • Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
  • Proactively anticipate risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions.
  • Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports or other staff responsible.

Requirements:

  • Bachelor's Degree, scientific discipline strongly preferred.
  • Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred.
  • 10+ years of pharmaceutical industry experience.
  • This is inclusive of 8 years of regulatory experience or combination of 6+ years regulatory and/or related experience.
  • Experience in reviewing, authoring, or managing components of regulatory submissions.
  • Expert knowledge of drug development process and regulatory requirements.
  • Knowledge of FDA, EU, Canada, ROW and post-marketing a plus.
  • Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy.

About Takeda:

Takeda is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to people worldwide. We are a patient-focused company that is transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs.

At Takeda, we are certified as a Global Top Employer and offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.