Regulatory Labeling Manager

1 week ago

Dublin, Dublin City, Ireland beBeeLabeling Full time $148,300 - $241,900

Job Summary:

The senior professional responsible for the development, review, approval, and maintenance of labeling documents across various product lifecycles requires expertise in regulatory labeling, leadership skills, and strategic thinking to manage complex programs and projects.

Key Responsibilities:

  • Manages the Regulatory labeling process throughout the product lifecycle
  • Leads the Labeling Working Group and manages development, review, approval, and maintenance of labeling for CCDS, USPI, EU SmPC, and RoW labeling
  • Develops and implements labeling strategies through interpretation of regulations, guidelines, and competitor analyses
  • Communicates effectively with various levels of management to enable decision-making
  • Provides labeling expertise on complex issues to stakeholders
  • Maintains labeling documents in electronic document management systems and relevant labeling trackers
  • Monitors worldwide regulation changes and maintains labeling SOP and work instructions

Requirements:

  • Bachelor's degree in Life Sciences or advanced degree in medicine or science is preferred
  • 3-4 years of related Biotech or Pharma industry experience, 2 or more of which are working with labeling
  • In-depth knowledge of the labeling process, industry practice, packaging manufacturing process, and drug development process
  • Familiarity with policies and operating procedures in medical safety regulatory and/or corporate and worldwide Regulatory Agencies

Why Join Us?

This role offers the opportunity to work in a dynamic environment that values diversity and comprehensive benefits. You will be part of a team that prioritizes innovation, collaboration, and growth.

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