Regulatory Advertising & Promotion Manager

The Manager of Regulatory Advertising & Promotion oversees the preparation and submission of FDA prescription drug promotional materials, ensuring compliance with advertising regulations. Key responsibilities include managing OPDP submissions using FDA Form 2253, verifying submission components, and performing quality-control checks. The role involves monitoring FDA regulatory updates, enforcement activities, and guidance documents to maintain compliance. Additionally, the manager develops and maintains policies, standard operating procedures, and training resources related to advertising regulations, supporting inspection readiness and responding to FDA inquiries. Qualifications include a bachelor's degree in life sciences, pharmacy, regulatory affairs, or related fields, with experience in regulatory affairs or advertising within the pharmaceutical or biotech industry. Ideal candidates have hands-on experience managing FDA OPDP submissions, a thorough understanding of FDA advertising regulations, attention to detail, strong document control skills, and familiarity with electronic submission systems. Compensation ranges from $104,400–$156,600.