Senior Director Regulatory Affairs, Advertising, Promotion & Labeling

My client is a commercial-stage leader focused on advancing non-opioid pain management and regenerative health solutions. Their innovative portfolio and pipeline are centered on addressing unmet patient needs while helping reduce reliance on opioids in modern medicine. This organization offers the opportunity to play a highly visible role within a mission-driven environment focused on improving patient outcomes.Position: The Senior Director, Regulatory Affairs, Advertising, Promotion & Labeling, is a key leadership role responsible for ensuring that commercial and promotional activities remain compliant with regulatory requirements while supporting broader business objectives. This individual will provide strategic regulatory leadership across advertising, promotional review, and product labeling activities for both commercial and investigational products.Key ResponsibilitiesAdvertising & Promotion:Provide regulatory leadership and strategic guidance to the Public Communications Review Committee (PCRC)Lead the review and approval of advertising and promotional materials for commercial and investigational products.Experience working with FDA's OPDP and submission of promotional materials.Serve as the primary regulatory liaison to Commercial, Medical Affairs, Legal, and other cross-functional teams.Develop and implement regulatory strategies and processes supporting promotional review activities.Maintain current expertise in FDA advertising and promotion regulations, enforcement trends, and guidance updates.Ensure consistency and alignment of promotional review practices across brands and therapeutic areas.Oversee regulatory submissions related to promotional materials and advertising activities.Labeling:Lead regulatory strategy and execution for USPI, EU PI, ROW labeling, and Company Core Data Sheets.Establish and oversee processes supporting labeling development, review, revision, and Health Authority submissions.Partner with Clinical Regulatory teams on labeling strategy and submission planningRepresent the organization in interactions with FDA OPDP and FDA Review Divisions regarding labeling matters.Support cross-functional initiatives focused on continuous improvement and operational excellence.LeadershipMentor and develop the Regulatory Affairs team members.Identify resource needs and manage internal and external support activities.Drive process improvements to support a scalable, efficient organization.Support budgeting, forecasting, and vendor management activities within Regulatory Affairs.Qualifications:Bachelor’s degree in Life Sciences required; advanced degree preferred.10+ years of progressive Regulatory Affairs leadership experience within the pharmaceutical industry.8+ years of experience in Regulatory Affairs, Advertising, Promotion, and Labeling in the pharmaceutical industry.Strong experience with FDA OPDP interactions and promotional material submissions.Expertise in advertising, promotion, and product labeling regulations for pharmaceutical, biologic, and/or medical device products.Strong experience in leading regulatory strategy and execution for USPI, EU PI, ROW labeling, and Company Core Data Sheets.Experience leading Medical, Legal, and Regulatory review processes.Proven leadership, communication, project management, and cross-functional collaboration skills.