Global Regulatory Labeling Strategy Leader

Takeda Pharmaceutical Co.; Warszawa; On-site; PLN 350,000 - 550,000; Full time

Benefits offered by this job

Healthcare stipend

Job summary

You will collaborate with Clinical, Safety, Medical Affairs, Commercial and Regulatory teams to drive strategy, manage content like USPI, EU SmPC and CCDS, and support health authority negotiations while guiding labeling governance.

Qualifications

• Bachelor's degree in a scientific discipline (or equivalent).
• 8+ years of pharmaceutical industry experience.
• At least 6 years of labeling experience or a combination of 5+ years in regulatory affairs and related disciplines.
• Strong knowledge of US and EU labeling regulations and requirements.
• Experience developing and maintaining USPI, EU SmPC, CCDS, and related labeling documentation.
• Demonstrated project leadership and cross-functional stakeholder management experience.

Responsibilities

• 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.
• Develop, update, and maintain key labeling documents, including USPI, SmPC, CCDS, CCDS Target Labeling Profiles.
• Incorporate emerging scientific, clinical, and safety information into labeling content.
• Support regulatory submissions and health authority negotiations.
• Build strong relationships across Clinical Development, Pharmacovigilance, Medical Affairs, Commercial, and Regulatory teams.
• Manage local labeling alignment activities, including exceptions and deferrals.
• Support affiliate responses to health authority requests and labeling-related inquiries.
• Monitor regulatory guidance, industry trends, and precedent decisions.
• Identify risks, propose mitigation strategies, and elevate issues appropriately.
• Contribute to inspections, audits, process improvements, and departmental initiatives.

Skills

Regulatory labeling

Cross-functional leadership

Project leadership

Regulatory strategy

Attention to detail

Education

Bachelor's degree in a scientific discipline

MSc/PhD/PharmD (preferred)

Job description

You will collaborate with Clinical, Safety, Medical Affairs, Commercial and Regulatory teams to drive strategy, manage content like USPI, EU SmPC and CCDS, and support health authority negotiations while guiding labeling governance.