Regulatory Affairs Director for Global Pharmaceutical Development

2 days ago


Lexington, Kentucky, United States Takeda Pharmaceutical Full time

Company Overview

Takeda Pharmaceutical is a world-class research and development organization committed to unlocking innovation and delivering transformative therapies to patients worldwide. Our company focuses on four therapeutic areas and other targeted investments, pushing the boundaries of what is possible in drug development.

Salary

The estimated base salary range for this position is $169,400 - $266,200 per year, depending on qualifications and experience. Takeda offers competitive compensation packages, including short-term and long-term incentives, medical insurance, 401(k) plans, and paid time off.

About the Role

We are seeking an experienced Regulatory Affairs Director to lead the execution of regulatory strategies for assigned products as part of our Global Regulatory Affairs team. As a key member of our team, you will independently develop and execute regulatory CMC investigational, registration, and post-approval strategies for assigned products. You will also represent and contribute to Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.

Key Responsibilities

  • Develop, execute, and oversee regulatory submissions preparation per the GRA CMC Product Team CMC strategy
  • Guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirements
  • Represent Takeda GRA CMC in Health Authority meetings and drive preparation activities for meetings with Health Authorities on CMC related matters
  • Provide guidance to the teams on administrative procedural topics while interacting with International Health Authorities

Requirements

  • Bachelor's or Master's degree in a scientific discipline, such as chemistry, biology, or pharmaceutical science
  • 10+ years of overall biopharmaceutical/device industry experience, with at least 8 years of pharmaceutical Regulatory CMC and/or devices experience
  • Leadership experience (3+ years) required, with proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams

About Us

Takeda is a patient-focused company that strives to deliver better health and a brighter future to people around the world. We foster an inclusive, collaborative workplace, where our teams are united by an unwavering commitment to excellence and patient care. This role is currently classified as hybrid, with opportunities to work remotely or from our office locations.



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