Director, Global Regulatory Labeling Strategy

Takeda is seeking a strategic regulatory leader to join its team as Director, Global Regulatory Labeling Strategy in the United States, shaping how product labeling is developed, governed, and aligned across global markets.

About the Role

As Director, Global Regulatory Labeling Strategy at Takeda, you will own the strategic direction for product labeling across Takeda's portfolio, ensuring that core labeling documents meet evolving regulatory expectations worldwide. This full-time, US-based position sits at the intersection of science, compliance, and cross-functional collaboration, giving you the opportunity to influence how critical product information reaches healthcare providers and patients. The role is office-based in the US (not remote).

Key Responsibilities

• Define and drive the global regulatory labeling strategy for assigned products throughout their lifecycle.
• Develop, maintain, and oversee company core labeling documents in line with applicable regulations and internal standards.
• Partner with regulatory affairs, medical, safety, legal, and commercial teams to align labeling decisions with broader product strategy.
• Interpret evolving health authority guidance and translate requirements into practical labeling actions.
• Provide expert guidance on labeling-related risks, negotiations, and submissions across global markets.
• Champion process improvements and consistency in labeling governance across Takeda's organization.

Qualifications

• Extensive experience in global regulatory affairs, with a strong focus on labeling strategy within the pharmaceutical or biotech industry.
• Deep understanding of international labeling regulations and health authority expectations.
• Proven leadership in steering cross-functional teams and managing complex, high-stakes regulatory deliverables.
• Excellent communication, analytical, and stakeholder-management skills.
• A degree in a relevant scientific, pharmacy, or life-sciences discipline (advanced degree preferred).
• Authorization to work in the United States.

About Takeda

Takeda is a global, values-driven biopharmaceutical company committed to discovering and delivering life-transforming treatments. Working at Takeda means contributing to better health for people and a brighter future for the world, supported by a culture rooted in patient focus, integrity, and continuous innovation.

How to Apply

Ready to lead global labeling strategy at Takeda? Submit your application for the Director, Global Regulatory Labeling Strategy role through Takeda's official application process. When you apply, your information will be handled in accordance with Takeda's Privacy Notice and Terms of Use, and you confirm that the details you provide are accurate to the best of your knowledge.