Regulatory Affairs Reviewer

Job Summary

To support its Promotional Review Committee, an experienced Regulatory Affairs Advertising & Promotion Reviewer will provide regulatory review of pharmaceutical advertising and promotional materials on a remote, contract basis, ensuring compliance with FDA regulations.

Key responsibilities

• Review promotional materials for compliance with FDA advertising and promotion regulations
• Participate in cross-functional Promotional Review Committee meetings as the Regulatory Advertising & Promotion representative
• Provide regulatory guidance to Marketing, Medical, Legal, and Commercial stakeholders regarding promotional claims and compliance initiatives

Required qualifications

• 10+ years of experience in Regulatory Advertising & Promotion review within the pharmaceutical or biotechnology industry
• Deep knowledge of FDA advertising and promotion regulations and review processes
• Experience with Core Labeling Facts (CFL) guidance; familiarity with SIUU guidance preferred
• Experience supporting Accelerated Approval biologic products is strongly preferred
• Prior experience in CNS or nephrology therapeutic areas is a plus