International Label Compliance Specialist

2 days ago

Dublin, Dublin City, Ireland beBeeGlobal Full time €90,000 - €120,000
Job Title

A Global Labelling Manager is required to join a leading pharmaceutical client.

About the Role

The successful candidate will be responsible for global product leadership, strategic planning and forecasting of label change projects. They will also ensure accuracy and completeness of the Brief phase within the Artwork Management System and compliance with regulatory requirements.

Key Responsibilities
  • Global product leadership for strategic planning and forecasting of label change projects
  • Responsibility for accuracy and completeness of the Brief phase within the Artwork Management System and to ensure compliance with regulatory requirements
  • Project Management responsibility within the system for Production, Design and Asset workflows
  • Lead label change projects and associated deliverables for launches, site transfers, country/area specific changes and other labelling focused projects
  • Lead the periodic formal review process for label change management and develop and report performance metrics within label change execution
  • Ownership and leadership role within the Packaging and Artwork Strategy
  • Lead shared label strategy development and maintenance over the product life cycle
  • Act as business process owner for specific labeling business processes and assume role of documentation subject matter expert
  • Lead role to represent GLM in early development labelling work including functioning as lead for labelling launch activity
Requirements
  • Bachelor's Degree in Science, Engineering, Business or Supply Chain
  • Extensive experience in Operations, Regulatory or Quality environment
  • Proficiency in English (both written and oral)
  • Experience working effectively across different cultures, multiple functional areas and in complex matrix environments
  • Excellent written and oral communication skills with all levels of management and personnel
  • Demonstrated success in negotiating and problem solving skills
  • Strong interpersonal and organisational skills
  • Excellent leadership skills and a proven ability to drive cross functional collaboration
  • Understanding of Regulatory, Quality and Supply Chain aspects of labelling and impact of non-compliance
  • Knowledge of applicable regulations and standards affecting Pharmaceutical, Device, Device/Combo Products, specifically regulations and standards affecting the Packaging and Labelling Quality System
What We Offer

This is an excellent opportunity for a skilled professional to join a dynamic team and make a real difference in the industry.

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