The role is responsible for developing, maintaining, and implementing Japan-specific product labeling to ensure safe and effective use of Amgen products
Job Summary
The role is responsible for developing, maintaining, and implementing Japan-specific product labeling to ensure safe and effective use of Amgen products.
Candidates must lead the end-to-end process for labeling changes, including drafting, review coordination, and finalization of approved text in alignment with global principles.
The position requires strong cross-functional communication to partner with Regulatory, Safety, Quality, and Commercial teams across the product lifecycle.
Matching Summary
The role is responsible for developing, maintaining, and implementing Japan-specific product labeling to ensure safe and effective use of Amgen products.
Skills & Requirements
Must-have
Japan labeling regulations knowledge
Package Insert authoring experience
Product lifecycle labeling management
Cross-functional stakeholder collaboration
English proficiency for global teams
Nice-to-have
Strategic guidance on labeling trends
Experience with workflow systems
Master's or Doctoral degree preferred
Key Requirements
Bachelor's degree in a scientific field
At least 5 years pharmaceutical regulatory experience