Manager, Global Labeling Product Leader

About the role

The Manager, Global Labeling Product Leader is responsible for the strategic development, revision, review and maintenance of primary and derived labeling documents for assigned compounds across multiple therapeutic areas. The role supports global regulatory strategy and ensures high‑quality, compliant labeling that meets stakeholder and patient needs.

Key responsibilities

• Lead the creation, revision and approval of primary labeling (CCDS, USPI, EU Product Information) and derived documents for assigned products.
• Provide 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 the end‑to‑end labeling process.
• Collaborate with cross‑functional teams in a matrix environment to ensure alignment and compliance.

Required profile

• Bachelor’s degree in a scientific discipline (advanced degree preferred).
• Minimum 4 years of pharmaceutical industry experience, with at least 3 years in regulatory affairs focusing on product labeling.
• Strong understanding of drug development, worldwide regulatory guidelines and labeling regulations.
• Proven ability to lead projects independently, prioritize multiple products and communicate scientific concepts effectively.

Required skills

• Experience with document management systems.
• Knowledge of global regulatory guidelines for labeling.