Global Regulatory Labeling Strategy Director

Takeda; United States; Remote; USD 177,000 - 278,000; Full time

Job summary

Takeda is seeking a Director of Global Regulatory Labeling Strategy to develop and implement labeling content and strategy for multiple products across development stages. You will lead cross-functional teams, author key labeling documents, and coordinate timely submissions with health authorities while ensuring compliance with global labeling requirements.

In this senior role, you will manage GLOC coordination, interact with senior management, and drive continuous improvements in labeling

Qualifications

• BSc degree, preferred; BA accepted.
• 10+ years of pharmaceutical industry experience, incl. 8 years labeling or 6+ years regulatory-related experience.
• Experience leading labeling teams and submissions.

Responsibilities

• Lead labeling cross-functional teams and align labeling strategy.
• Author and manage CCDS, USPI, and EU SmPC for products with input from functions.
• Coordinate labeling submissions and negotiations with health authorities.
• Ensure compliance with regulatory labeling requirements across regions.
• Manage local labeling alignment with CCDS and support local affiliates.
• Develop strategic labeling plans and monitor labeling trends and precedents.

Skills

Labeling strategy

Regulatory submissions

Project management

Cross-functional leadership

Stakeholder management

Education

BSc/BA in science

Advanced scientific degree (MSc/PhD/PharmD) preferred

Job description

Takeda is seeking a Director of Global Regulatory Labeling Strategy to develop and implement labeling content and strategy for multiple products across development stages. You will lead cross-functional teams, author key labeling documents, and coordinate timely submissions with health authorities while ensuring compliance with global labeling requirements.

In this senior role, you will manage GLOC coordination, interact with senior management, and drive continuous improvements in labeling