🚀 Regulatory Affairs Manager

A company is looking for a Sr Manager Regulatory Affairs - Labeling, Advertising and Promotions (Remote).

Key Responsibilities

• Guide and coordinate regulatory strategy for labeling, advertising, and promotions for product launches
• Maintain oversight of promotional and labeling systems for managing review and approval processes
• Organize cross-functional meetings for change controls and manage submissions to regulatory authorities

Required Qualifications

• Bachelor's degree in science with 10+ years of experience in Regulatory Affairs
• Regulatory affairs certification (RAC) preferred
• Experience in preparing regulatory submissions and knowledge of electronic submission processes
• Strong understanding of the global pharmaceutical regulatory environment, particularly in North America
• Demonstrated experience in managing change controls and promotional materials in a pharmaceutical organization