Global Regulatory Labeling Strategy Lead

POL - 6999 Takeda SCE; Warszawa; On-site; PLN 260,000 - 380,000; Full time

Job summary

Takeda in Warsaw seeks an experienced regulatory professional to lead global labeling strategy and drive cross‑functional labeling initiatives across development and commercialization stages.

You will shape and maintain global labeling, partnering with Clinical, Safety, Medical Affairs, Commercial, and Regulatory teams to influence outcomes and support health authority negotiations worldwide.

Qualifications

• Bachelor's degree in a scientific discipline (or equivalent).
• 8+ years in pharmaceutical industry.
• At least 6 years in labeling or 5+ years in regulatory affairs-related disciplines.
• Strong knowledge of US and EU labeling regulations.
• Experience drafting USPI, EU SmPC, CCDS.

Responsibilities

• Lead Global Labeling Strategy.
• Drive the development and implementation of labeling strategies for assigned products.
• Lead cross-functional labeling teams, ensuring alignment on content, timelines, and strategic direction.
• Coordinate approval processes through senior governance forums and cross-functional stakeholders.
• Author and Manage Labeling Documents.
• Develop, update, and maintain CCDS, USPI, EU SmPC documentation.
• Support regulatory submissions and health authority negotiations.
• Partner with Global Stakeholders across Clinical Development, Pharmacovigilance, Medical Affairs, Commercial, and Regulatory functions.
• Manage local labeling alignment activities, including exceptions and deferrals.
• Drive Regulatory Excellence by monitoring guidance and industry trends.
• Oversee external vendors supporting labeling activities.

Skills

Global labeling strategy

US/EU labeling regs

Cross-functional leadership

Regulatory submissions

Project management

Labeling documents

Education

Bachelor's degree in a scientific discipline

MSc/PhD/PharmD preferred

Job description

Takeda in Warsaw seeks an experienced regulatory professional to lead global labeling strategy and drive cross‑functional labeling initiatives across development and commercialization stages.

You will shape and maintain global labeling, partnering with Clinical, Safety, Medical Affairs, Commercial, and Regulatory teams to influence outcomes and support health authority negotiations worldwide.