Director of Regulatory Labeling

Job Summary

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