Manager - Labeling

Amgen Inc

Not specified
End to end labeling initiatives experience
Global labeling compliance knowledge
Regional regulatory labeling expertise
Amgen Inc is seeking a Manager for their Global Labeling Process Management team, responsible for ensuring timely launches and compliance with labeling processes. The role involves collaboration with various stakeholders, project management, and mentoring junior staff while maintaining regulatory standards

Job Summary

  • The LPM Manager supports the Global Labeling Process Management team to ensure timely Amgen product launches and provide expert labeling knowledge.
  • Key responsibilities include collaborating with local affiliates and regulatory affairs to plan label changes while ensuring strict compliance with regional regulations.
  • The role requires managing translations for international markets, maintaining inspection readiness, and serving as the primary contact for internal and external audits.

Matching Summary

Match Score: 85

Amgen Inc is seeking a Manager for their Global Labeling Process Management team, responsible for ensuring timely launches and compliance with labeling processes. The role involves collaboration with various stakeholders, project management, and mentoring junior staff while maintaining regulatory standards.

Skills & Requirements

Must-have

  • End to End Labeling Initiatives experience
  • Global labeling compliance knowledge
  • Regional regulatory labeling expertise
  • Artwork source text management
  • Change Control regulatory assessments

Nice-to-have

  • Mentoring junior team members
  • Continuous improvement practices
  • External industry committee visibility
  • Strong negotiation skills
  • Tolerance for ambiguity

Key Requirements

  • Bachelor's or Master's degree
  • Minimum 8 years of labeling experience
  • Experience in HA Regulations and International Markets
  • Individual Contributor role capability

Work Rights

Not specified

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