Manager, Global Labeling Product Leader

About the role

The Manager, Global Labeling Product Leader will lead the development, revision, review, agreement and maintenance of primary and derived labeling documents for assigned compounds across multiple therapeutic areas.

Key responsibilities

• Lead end‑to‑end labeling process, ensuring high‑quality, compliant labeling for CCDS, USPI, EU Product Information and derived documents.
• Provide recommendations, advice and guidance on labeling content, timelines and scientific integrity, and coordinate resolution of labeling issues.
• Contribute to global labeling strategy, competitor analysis and continuous improvement of labeling processes.

Required profile

• Minimum Bachelor’s degree in a scientific discipline; advanced degree (MS, PhD, MD or PharmD) preferred.
• At least 4 years of pharmaceutical industry experience, with 3+ years in Regulatory Affairs focusing on product labeling.
• Strong understanding of drug development, worldwide regulatory guidelines and labeling regulations.
• Proven ability to lead project teams in a matrix environment and manage multiple products simultaneously.

Required skills

• Regulatory Affairs expertise, especially labeling regulations.
• Experience with document management systems.
• Analytical reasoning and strategic thinking.