Global Regulatory Labeling Strategy Director (Hybrid)

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

Job summary

Takeda in Lodz, Poland, is seeking a Director, Global Regulatory Labeling Strategy to shape global labeling across a diverse portfolio. This hybrid role blends scientific expertise with regulatory strategy and cross‑functional leadership to deliver CCDS, USPI, and EU SmPC documents and to influence strategy at senior governance levels.

You will lead global labeling for products across development stages, collaborate with Safety, Clinical Development, Medical Affairs, Regulatory Strategy, and

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.

Responsibilities

• Lead global labeling strategy for multiple products across development stages and lifecycle management.
• Author and oversee labeling documents: CCDS, USPI, EU SmPC, Target Labeling Profiles (TLP).
• Drive cross-functional collaboration with Safety, Clinical Development, Medical Affairs, Regulatory Strategy, Commercial and other stakeholders.
• Lead discussions and present recommendations to senior governance and leadership forums.
• Develop strategic labeling positions based on data, precedent, and regulatory expectations.
• Support global implementation of labeling updates ensuring regulatory compliance.

Skills

Cross-functional leadership

Strong presentation skills

Influencing senior leadership

Regulatory strategy

Regulatory labeling

Education

Bachelor's degree in a scientific discipline

MSc, PharmD, PhD (preferred)

Job description

Takeda in Lodz, Poland, is seeking a Director, Global Regulatory Labeling Strategy to shape global labeling across a diverse portfolio. This hybrid role blends scientific expertise with regulatory strategy and cross‑functional leadership to deliver CCDS, USPI, and EU SmPC documents and to influence strategy at senior governance levels.

You will lead global labeling for products across development stages, collaborate with Safety, Clinical Development, Medical Affairs, Regulatory Strategy, and