Director, US Regulatory Affairs, Advertising & Promotion

Director-level regulatory affairs position overseeing FDA compliance for promotional materials, marketing campaigns, and medical communications at a cardiovascular biopharmaceutical company. Requires strategic leadership, cross-functional collaboration, and expertise in advertising and promotion regulations.

Responsibilities

• Lead regulatory review and approval of US product promotional materials and ensure claims compliance
• Manage FDA submissions including Form 2253 and voluntary advisory comments
• Mentor junior regulatory professionals and drive continuous process improvement
• Train marketing, sales, and medical affairs teams on regulatory compliance requirements
• Monitor OPDP enforcement trends and communicate updates to cross-functional stakeholders

Requirements

• Bachelor's degree required; PharmD, PhD, or JD preferred
• Minimum 10 years pharmaceutical or biotechnology regulatory affairs experience
• At least 7 years focused on US advertising and promotion
• Proven track record launching drug or biologic products
• Direct experience managing OPDP interactions and submissions
• Expert knowledge of FDA regulations for biologics and promotional compliance
• Proficiency with Veeva Vault PromoMats electronic review systems

Compensation: $225,000-$262,500 base salary