Global Regulatory Labeling Director - Hybrid (Poland)

Takeda; Warszawa; Hybrid; PLN 421,000 - 579,000; Full time

Job summary

Takeda in Poland is seeking a Director, Global Regulatory Labeling Strategy to lead global labeling strategy across multiple products, author CCDS/USPI/EU SmPC documents, and partner with Safety, Clinical Development, Medical Affairs, Regulatory Strategy, and Commercial teams.

The role requires 10+ years in pharma labeling, strong leadership, and capability to influence governance while building Poland-based regulatory capability.

Qualifications

• Bachelor's degree in a scientific discipline.
• 10+ years of pharmaceutical industry experience.
• Significant experience in global regulatory labeling and/or regulatory affairs.
• Demonstrated expertise authoring and managing CCDS, USPI, and EU SmPC documents.
• Experience leading cross-functional teams and driving consensus among diverse stakeholders.
• Strong presentation, communication, and influencing skills.
• Experience presenting to senior leadership or governance bodies.

Responsibilities

• Lead global labeling strategy for multiple products across development and lifecycle stages.
• Author and oversee labeling documents: CCDS, USPI, EU SmPC, TLP.
• Drive cross-functional collaboration with Safety, Clinical Development, Medical Affairs, Regulatory Strategy, and Commercial teams.
• Lead discussions and present recommendations to senior governance and leadership forums.
• Develop strategic labeling positions by evaluating data, competitor labeling, and regulatory precedent.
• Support global implementation of labeling updates while ensuring compliance and operational excellence.
• Partner with vendors and operational teams for end-to-end labeling delivery.
• Serve as a leadership presence and subject matter expert within the Poland organization.

Skills

Global labeling strategy

Cross-functional leadership

Strategic influence

Communication & presentation

Education

Bachelor's degree in a scientific discipline

Job description

Takeda in Poland is seeking a Director, Global Regulatory Labeling Strategy to lead global labeling strategy across multiple products, author CCDS/USPI/EU SmPC documents, and partner with Safety, Clinical Development, Medical Affairs, Regulatory Strategy, and Commercial teams.

The role requires 10+ years in pharma labeling, strong leadership, and capability to influence governance while building Poland-based regulatory capability.