Director, US Regulatory Affairs, Advertising & Promotion

Role: Director of Regulatory Affairs, Advertising and Promotion, overseeing U.S. regulatory review and compliance for commercial and promotional materials in a cardiovascular biopharma. Responsibilities include leading FDA review processes, ensuring claim substantiation, managing OPDP interactions, and mentoring staff. The role entails strategic regulatory guidance for marketing and medical communication, developing SOPs, and training cross-functional teams on compliance practices. Qualifications: Bachelor’s degree (PharmD, PhD, JD preferred), 10+ years in pharma/biotech regulatory affairs with at least 7 years focused on U.S. advertising and promotion, with a proven track record of successful product launches. Skills include expert FDA regulation knowledge, proficiency with Veeva Vault PromoMats, and strong communication abilities. High-value specifics: focus on biologics, regulatory compliance, FDA interactions, and promotional review within a biopharma setting. Work setup details are not specified; travel requirements are not indicated.