Senior Manager Regulatory Labeling Specialist

1 week ago


Dublin, Dublin City, Ireland beBeeRegulatory Full time $148,300 - $241,900
Job Title:

The Regulatory Labeling Manager is a strategic leader responsible for the development, review, approval, and maintenance of regulatory labeling documents. They drive compliance with FDA, EMA, and international regulations through effective labeling strategies.

Key Responsibilities:
  • Develops and implements labeling strategies to ensure global regulatory compliance.
  • Leads cross-functional teams to address complex labeling issues and oversee project completion.
  • Provides expert guidance on labeling regulations and communicates business implications to stakeholders.
  • Maintains knowledge of worldwide regulation changes and updates labeling SOP and work instructions accordingly.

This role requires an experienced professional with in-depth knowledge of FDA, EMA, and international labeling regulations, ICH guidelines, and CIOMS core labeling guidelines.

A Bachelor's degree in Life Sciences or related field is required; an advanced degree is preferred. The ideal candidate should have at least 3-4 years of experience in the Biotech or Pharma industry, with a minimum of 2 years working with labeling and regulatory compliance.



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