Regulatory Affairs Manager

Job Summary

Joining the Legal team, the full-time Regulatory Affairs Manager will evaluate advertising and promotional materials for FDA compliance, collaborating cross-functionally while working remotely or from New York, NY.

Key responsibilities

• Participate in the advertising review process, ensuring compliance of creative assets with FDA regulations
• Review product claims and assess regulatory risks associated with proposed claims
• Maintain and update company-wide advertising and promotion guidelines and databases

Required qualifications

• 4-7 years of relevant industry experience
• MS or PharmD preferred, or experience in a regulated product industry or telehealth
• Strong knowledge of FDA advertising and promotion regulations
• Ability to understand scientific papers and clinical trial results
• Experience providing regulatory recommendations with supervisory input