Advertising and Promotion Regulatory Specialist

We are seeking a seasoned regulatory professional to provide critical guidance on advertising and promotion policies, ensuring compliance with FDA regulations and industry standards. Job Description: The successful candidate will be responsible for providing regulatory advice to marketing teams, legal, medical affairs, and clinical research on advertising and promotion for the US market. Key Responsibilities: • Provide regulatory advice to marketing teams, legal, medical affairs, and clinical research on advertising and promotion for the US market • Knowledge of FDA regulations governing product promotion • Position promotional materials in accordance with FDA regulations, policies, and guidelines • Interact with OPDP/APLB, including supporting responses to regulatory inquiries and preparing submissions for advisory comments • Assist in developing US labeling to support anticipated promotional messages and claims • Monitor OPDP/APLB research, guidance, and enforcement activities, and communicate learnings to stakeholders Requirements: • Bachelor's degree • 3+ years of regulatory experience in pharmaceutical advertising and promotion for the US market • Prior work experience interacting with OPDP and/or APLB reviewers • Experience working on pre-launch activities and launch promotional campaigns GSK is an Equal Opportunity Employer committed to diversity, equity, and inclusion.

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