Senior Director of Global Labeling

Job Summary

Leading the global labeling function, the full-time Senior Director of Global Labeling will define and execute labeling strategies, manage FDA negotiations, and develop a high-performing labeling team while working remotely.

Key responsibilities

• Define the global labeling vision, priorities, and strategy across development-stage and marketed products
• Serve as the senior regulatory authority for labeling strategy and lead preparation for FDA labeling negotiations
• Build and develop a high-performing global labeling organization, overseeing internal FTEs and external resources

Required qualifications

• Minimum of 15 years of relevant biopharmaceutical industry experience, including substantial Regulatory Affairs experience
• Advanced scientific or clinical degree preferred
• Demonstrated experience leading FDA labeling negotiations for original NDA/BLA approvals
• Strong understanding of FDA labeling requirements and experience developing Company Core Data Sheets (CCDS) and US Prescribing Information (USPI)
• Proven leadership experience managing and developing internal teams in a matrixed environment