Manager, Global Labeling Product Leader

Johnson & Johnson seeks a Manager for Global Labeling Product Leader to lead strategic development and lifecycle management of product labeling across therapeutic areas and regions. The role manages primary and derived labeling documents, coordinates regulatory compliance, and contributes to continuous process improvement within the Global Regulatory Affairs function.

Responsibilities

• Lead development, revision, review, and maintenance of primary labeling documents including CCDS, USPI, and EU Product Information
• Provide recommendations and guidance on labeling content, processes, timelines, and scientific integrity across assigned compounds
• Coordinate resolution of labeling issues affecting primary, derived labeling, or supporting documentation
• Contribute to global labeling strategy, including competitive analysis and target labeling development
• Drive continuous improvement of the end-to-end labeling process

Requirements

• Bachelor's degree in scientific discipline; advanced degree (MS, PhD, MD, PharmD) preferred
• Minimum 4 years pharmaceutical industry experience in regulatory affairs, clinical, medical information, or pharmacovigilance
• Minimum 3 years regulatory affairs experience with product labeling and labeling regulations preferred
• Understanding of pharmaceutical drug development and ability to communicate scientific concepts
• Knowledge of worldwide regulatory guidelines and their labeling applications
• Experience leading project teams in matrix environments with ability to work independently
• Proficiency with document management systems and demonstrated project prioritization skills

Compensation: €82,000.00 - €141,450.00