Senior Regulatory Labeling Manager

A company is looking for a Senior Manager, Regulatory Labeling. Key Responsibilities Manage the Regulatory labeling process throughout the product lifecycle Lead the Labeling Working Group and oversee the development, review, approval, and maintenance of various labeling documents Provide labeling expertise and prepare submission-ready labeling documents while monitoring worldwide regulation changes Required Qualifications Bachelor's degree in Life Sciences; advanced degree preferred 3-4+ years of related Biotech or Pharma industry experience, with 2+ years in labeling In-depth knowledge of the labeling process and drug development Familiarity with regulatory policies and procedures Expert knowledge of FDA, EMA, and international labeling regulations

May 6, 2025 - 01:08
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Senior Regulatory Labeling Manager
A company is looking for a Senior Manager, Regulatory Labeling. Key Responsibilities Manage the Regulatory labeling process throughout the product lifecycle Lead the Labeling Working Group and oversee the development, review, approval, and maintenance of various labeling documents Provide labeling expertise and prepare submission-ready labeling documents while monitoring worldwide regulation changes Required Qualifications Bachelor's degree in Life Sciences; advanced degree preferred 3-4+ years of related Biotech or Pharma industry experience, with 2+ years in labeling In-depth knowledge of the labeling process and drug development Familiarity with regulatory policies and procedures Expert knowledge of FDA, EMA, and international labeling regulations