Regulatory Labeling Manager

Job Summary

A company is looking for a Regulatory Labeling Manager to support the end-to-end labeling processes for pre- and post-marketed products.

Key Responsibilities

• Author and maintain core company labeling documents for global marketing applications
• Lead cross-functional teams to align on labeling text and strategies for product launches
• Provide strategic guidance on labeling regulations and manage responses to health authority queries

Required Qualifications

• Doctorate degree, or a Master's degree with 2 years of related experience, or a Bachelor's degree with 4 years of related experience
• Experience in authoring and developing pharmaceutical or biotechnology product labeling
• Knowledge of FDA, EMA, or other international regulations for prescribing information labeling
• Project management experience with moderate complexity projects
• Experience with Veeva-based RIM Regulatory Management systems