Japan Labeling Lead (sr Associate Or Manager)

Amgen UK

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

Job Summary

  • The role is responsible for driving Japan labeling strategy and end-to-end execution across the entire product lifecycle.
  • Candidates must ensure consistency between Japan-specific labeling content and global labeling principles while meeting local regulatory requirements.
  • The position requires strong collaboration with cross-functional partners including Regulatory, Safety, Quality, and Commercial teams to align labeling updates.

Matching Summary

The role is responsible for driving Japan labeling strategy and end-to-end 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
  • Risk minimization alignment

Key Requirements

  • Bachelor's degree in scientific field
  • At least 5 years pharmaceutical industry experience
  • Working knowledge of PMD Act labeling provisions
  • Experience creating and maintaining PI documents

Work Rights

Not specified

Tailored Resume

Cover Letter