Global Regulatory Labeling Lead

Job Summary

Driving the regulatory labeling strategy for the Plasma-Derived Therapies Business Unit, the full-time Associate Director, Global Regulatory Labeling Lead will provide strategic guidance on drug and device labeling while collaborating with cross-functional teams in a hybrid work environment.

Key responsibilities

• Develops and manages labeling strategies, including the Company Core Data Sheet and regional labels
• Interprets scientific data to optimize product labeling and patient benefit-risk ratios
• Leads cross-functional teams to ensure compliance with internal and Health Authority labeling requirements

Required qualifications

• Minimum of 7-10 years of experience in the biopharmaceutical industry, with 5-7 years in a global labeling role
• Detailed understanding of US and EU labeling regulations and guidance
• Experience with plasma-derived therapies and biologics preferred
• Bachelor's or Master's degree required; advanced scientific degree preferred
• Proficiency in Electronic Document Management Systems and labeling tracking systems