Japan Labeling Lead (sr Associate Or Manager)

Amgen Inc

Japan labeling regulations knowledge
Package insert authoring experience
Product lifecycle management
The role is responsible for driving Japan-specific product labeling strategy and execution across the entire product lifecycle

Job Summary

  • The role is responsible for driving Japan-specific product labeling strategy and execution across the entire product lifecycle.
  • Candidates must ensure alignment between Japanese regulatory requirements and global labeling principles while managing Package Inserts and packaging components.
  • The position requires close collaboration with cross-functional teams including Regulatory, Safety, Quality, and Commercial to support high-quality compliant labeling.

Matching Summary

The role is responsible for driving Japan-specific product labeling strategy and execution across the entire product lifecycle.

Skills & Requirements

Must-have

  • Japan labeling regulations knowledge
  • Package Insert authoring experience
  • Product lifecycle management
  • Cross-functional stakeholder collaboration
  • English proficiency for global teams

Nice-to-have

  • Strategic guidance on labeling trends
  • Master's or Doctoral degree preferred
  • Experience with workflow systems
  • Strong communication skills

Key Requirements

  • Bachelor's degree in scientific field
  • 5+ years pharmaceutical industry experience
  • Working knowledge of PMD Act labeling provisions

Work Rights

Not specified

Tailored Resume

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