Manager, Regulatory Advertising & Promotion

Role: Manager, Regulatory Advertising & Promotion responsible for managing FDA OPDP submissions for prescription drug promotional materials, ensuring compliance with FDA regulations, and maintaining accurate submission records. Responsibilities include preparing and coordinating FDA submissions (Form FDA 2253), verifying materials, troubleshooting submission issues, and supporting responses to FDA inquiries. Additionally, the role involves monitoring FDA regulatory updates, developing policies and training on advertising compliance, and supporting inspection readiness. Qualifications: Bachelor's degree in life sciences, pharmacy, regulatory affairs, or related field; 5+ years in pharmaceutical/biotech regulatory affairs, with experience in FDA-regulated promotional materials and OPDP submissions preferred. Skills include strong attention to detail, knowledge of Form FDA 2253 and electronic submission systems like Veeva PromoMats, and effective cross-functional collaboration. High-value specifics: Experience supporting marketed prescription drugs in the U.S., familiarity with FDA enforcement trends, and supporting high-volume promotional activities are advantageous. The role offers flexible working arrangements (20-40% remote) and may involve some travel, with a salary range of $104,400–$156,600 for US-based candidates.