Global Labeling Lead

Job Summary

Leading all labeling activities for BioNTech's commercial products, the full-time remote Global Labeling Lead will define and execute labeling strategies, manage cross-functional teams, and ensure timely updates of regulatory labeling content.

Key responsibilities

• Define and execute labeling strategy for global life cycle management of medicinal products
• Build and lead cross-functional labeling teams to ensure timely updates and communication of labeling content
• Identify and resolve critical regulatory labeling issues, leading initiatives across functions

Required qualifications

• Degree in pharmacy, chemistry, biology, biochemistry, medicine, or equivalent; advanced degree preferred
• 9-16 years of professional experience in Regulatory Affairs for Biologics, Vaccines, and/or Small Molecules
• Experience in strategic labeling content development and management, including interaction with Health Authorities
• In-depth knowledge of EMA and FDA regulatory requirements for product prescribing and patient information
• Ability to work independently on complex projects with minimal oversight