Japan Labeling Lead

• Drive Japan labeling strategy and execution for assigned products across the lifecycle
• Lead and/or coordinate the development and maintenance of Japan labeling content
• Provide strategic input on Japan labeling requirements, expectations, and trends to cross-functional stakeholders and Global Labeling partners
• Manage end-to-end processes for Japan labeling changes
• Coordinate labeling-related packaging component content and ensure accurate implementation
• Partner with Global Labeling, Regulatory, Safety, Quality, Supply Chain, and Commercial/Medical
• Support preparation of labeling-relevant submission materials and responses to health authority queries
• Conduct regulatory review of promotional and non-promotional materials

• Bachelor’s degree (preferably in a scientific field)
• At least 5 years of pharmaceutical industry experience in regulatory-related activities
• Working knowledge of Japan labeling regulations and requirements (PMD Act–related labeling provisions)
• Experience in authoring and maintaining PI and labeling-related component text across the product lifecycle
• Ability to provide strategic guidance on labeling considerations and to align Japan needs with global labeling principles
• Strong cross-functional communication and stakeholder management skills
• English proficiency for global collaboration, document review, and email communication
• Proficiency with document and workflow systems used for labeling content and review coordination

Master’s or Doctoral degree