Japan Labeling Lead (sr Associate Or Manager)

Amgen UK

Tokyo, Japan
On-site
Japan labeling regulations
Package inserts (pi) authoring
Global labeling principles alignment
Amgen UK is seeking a Japan Labeling Lead (Senior Associate or Manager) to oversee the development and implementation of Japan-specific product labeling in compliance with local regulations. The role involves strategic collaboration with various stakeholders throughout the product lifecycle to ensure high-quality and compliant labeling

Job Summary

  • The purpose of the Japan Labeling group is to develop, maintain, and implement Japan-specific product labeling that supports the safe and effective use of Amgen products and meets local regulatory requirements.
  • Responsible for Japan labeling strategy and end-to-end labeling execution across the product lifecycle, including the development, maintenance, and implementation of Japan labeling content for Package Inserts (PI), and labeling-related packaging components.
  • Partner with Global Labeling, Regulatory, Safety, Quality, Supply Chain, and Commercial/Medical to align labeling updates with scientific data, risk minimization, and regulatory commitments.

Matching Summary

Match Score: 85

Amgen UK is seeking a Japan Labeling Lead (Senior Associate or Manager) to oversee the development and implementation of Japan-specific product labeling in compliance with local regulations. The role involves strategic collaboration with various stakeholders throughout the product lifecycle to ensure high-quality and compliant labeling.

Skills & Requirements

Must-have

  • Japan labeling regulations
  • Package Inserts (PI) authoring
  • Global labeling principles alignment
  • Cross-functional stakeholder management
  • English proficiency for global collaboration

Nice-to-have

  • Strategic input on labeling trends
  • Promotional material regulatory review

Key Requirements

  • At least 5 years of pharmaceutical industry experience
  • Bachelor’s degree (preferably in a scientific field)
  • Working knowledge of Japan labeling regulations

Work Rights

Not specified

Tailored Resume

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