Regulatory Labeling Director

1 day ago

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

Job Overview:

The Regulatory Labeling Director oversees the entire labeling lifecycle, ensuring accurate and compliant documentation for products across various stages.

This role requires expertise in international regulations, including FDA, EMA, and ICH guidelines, as well as CIOMS core labeling standards.

  • Leads complex labeling programs with minimal oversight
  • Develops comprehensive labeling strategies through analysis of regulatory requirements and competitor intelligence
  • Effectively communicates labeling rationales to senior management for informed decision-making
  • Provides expert guidance on labeling matters to stakeholders

Responsibilities:

  1. Manage the labeling process throughout the product lifecycle
  2. Lead the development of target labeling documents to support clinical trial design and analysis plans
  3. Communicate potential impacts to product portfolios
  4. Maintain labeling documents in electronic systems and relevant trackers
  5. Contribute to group development through knowledge sharing and mentoring junior staff

Requirements:

  • Bachelor's degree from an accredited institution in Life Sciences or related field
  • Advanced degree (Masters, Pharm D, Ph.D, MD, DO) preferred in medicine or science
  • 3-4 years of experience in Biotech or Pharma industry, 2+ years working with labeling
  • In-depth knowledge of labeling processes, industry practices, packaging manufacturing, and drug development
  • Familiarity with policies and procedures in medical safety, corporate, and worldwide regulatory agencies

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