Regulatory Review Consultant

Job Summary

To support a growing regulatory team, the part-time Regulatory Promotional Review Consultant will oversee the promotional review process, provide compliant solutions for marketing materials, and act as the lead during Promotion Review Committee meetings while working remotely.

Key responsibilities

• Review and approve promotional and non-promotional materials for assigned brands, ensuring compliance with FDA regulations
• Lead the promotional review process and provide strategic regulatory guidance during PRC meetings
• Monitor the US regulatory promotional environment and stay updated on relevant FDA regulations and guidances

Required qualifications

• Bachelor's degree in Medical, Science, Marketing, Business, or Communications; PharmD preferred
• 5+ years of experience in the pharmaceutical or biotech industry, with a focus on regulatory advertising and promotion
• Proven experience in medical advertising and promotional review
• Strong project and process management experience in the pharmaceutical industry
• Familiarity with FDA guidelines and the advertising/creative development process