Director of Regulatory Labeling

A company is looking for a Director, 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 coordinate strategies across program-specific deliverables and junior team members Required Qualifications Bachelor's degree in Life Sciences; advanced degree preferred 10+ years of experience in the Biotech or Pharma industry, with at least 6 years in labeling In-depth knowledge of FDA, EMA, and international labeling regulations Ability to think strategically and propose risk management strategies Experience in leading complex labeling projects and working independently

Jun 13, 2025 - 19:20

A company is looking for a Director, 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 coordinate strategies across program-specific deliverables and junior team members Required Qualifications Bachelor's degree in Life Sciences; advanced degree preferred 10+ years of experience in the Biotech or Pharma industry, with at least 6 years in labeling In-depth knowledge of FDA, EMA, and international labeling regulations Ability to think strategically and propose risk management strategies Experience in leading complex labeling projects and working independently