Director of Regulatory Affairs

Job Summary

To advance regulatory compliance in promotional activities, the full-time remote Director of Regulatory Affairs will manage the review and approval of US promotional materials, medical communications, and social media postings for assigned brands while providing regulatory guidance and leading interactions with the FDA Office of Prescription Drug Promotion.

Key responsibilities:

• Serve as the internal subject matter expert on FDA Advertising & Promotion matters for assigned products, providing regulatory advice and solutions for compliance
• Review and approve promotional and medical materials in Definium's PromoMats system and represent the regulatory perspective in MLR meetings
• Liaise with OPDP/APLB (FDA) for assigned products, managing interactions and ensuring timely submissions of promotional materials

Required qualifications:

• Minimum BS in a scientific discipline; advanced degree in science preferred
• At least 10 years of experience in the pharmaceutical industry, with a minimum of 5 years as a regulatory advertising and promotional reviewer
• Expert knowledge of advertising promotion regulations and FDA Guidance documents
• Solid experience with promotional and medical review supporting product communications and working with FDA (OPDP, APLB)
• Experience with Veeva PromoMats is a strong plus