Global Regulatory Labeling Strategy Director

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

Benefits offered by this job

Hybrid work model

Job summary

Takeda Pharmaceutical Co. in Poland (Lodz) is seeking a Director, Global Regulatory Labeling Strategy to lead the global labeling strategy for a diverse portfolio.

Hybrid work in Poland with exposure to senior governance forums and cross-functional teams across Safety, Clinical Development, Medical Affairs, Regulatory Strategy, and Commercial. You will author CCDS, USPI, and EU SmPC documents, guide labeling positions, and drive regulatory strategy aligned with health authority expectations.

Qualifications

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

Responsibilities

• Lead global labeling strategy for products across development and lifecycle.
• Author and oversee CCDS, USPI, and EU SmPC documents.
• Drive cross-functional collaboration with Safety, Clinical Development, Medical Affairs, Regulatory Strategy, and Commercial.
• Lead discussions and present recommendations to governance forums.
• Develop strategic labeling positions based on data, precedent, and expectations.
• Support global implementation of labeling updates and vendor coordination.

Skills

Regulatory labeling

Cross-functional leadership

Executive presentation

Education

Bachelor's degree in science

Job description

Takeda Pharmaceutical Co. in Poland (Lodz) is seeking a Director, Global Regulatory Labeling Strategy to lead the global labeling strategy for a diverse portfolio.

Hybrid work in Poland with exposure to senior governance forums and cross-functional teams across Safety, Clinical Development, Medical Affairs, Regulatory Strategy, and Commercial. You will author CCDS, USPI, and EU SmPC documents, guide labeling positions, and drive regulatory strategy aligned with health authority expectations.