Director, Regulatory Affairs, Advertising & Promotion (Remote)

<div><p><b>Director, Regulatory Affairs, Advertising & Promotion (Remote)</b></p><br/><p>In this role, you will lead advertising and promotion regulatory strategy, shape product messaging, and support compliant commercialization activities while collaborating with Commercial, Medical Affairs, Legal, and Regulatory stakeholders.</p><br/><p><b>When & where:</b></p><br/><ul><li>Work Location: Remote - United States</li><li>Remote:5 days per week on site</li></ul><br/><p><b>Discover your role:</b></p><br/><ul><li>Lead US and global regulatory activities supporting advertising, promotion, and commercialization initiatives.</li><li>Advise on product messaging and promotional materials across functional areas. </li><li>Provide regulatory guidance for conference exhibits, disease awareness, and speaker programs. </li><li>Review promotional and disease-state communications for compliance with applicable requirements. </li><li>Partner with Marketing, Medical Affairs, Legal, and Regulatory Therapeutic Area Leads. </li><li>Oversee FDA promotional interactions, advisory submissions, and Form 2253 compliance. </li><li>Drive process improvements and portfolio-wide promotional policy standardization. </li><li>You build trusted relationships that influence decisions across complex stakeholder groups.</li></ul><br/><p><b>This role requires:</b></p><br/><ul><li>Master's, PharmD, or PhD; or a Bachelor's degree in Life Sciences from an accredited institution. </li><li>Minimum 7 years of biotechnology or pharmaceutical industry experience.</li><li>Deep expertise in advertising and promotion regulations, guidance, and development precedents. </li><li>Experience supporting pharmaceutical products; biologics experience is a plus. </li><li>Experience working directly with FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotional Labeling Branch (APLB). </li><li>Experience reviewing promotional materials and supporting product launches or campaigns. • Knowledge of commercialization strategy, labeling development, and marketing application content. </li><li>Experience with global promotional review, clinical trial recruitment materials, and labeling regulations preferred. </li><li>Experience leading teams, influencing cross-functional stakeholders, and working with senior management. </li><li>Strong written and verbal communication skills for strategic regulatory guidance.</li></ul><br/><p><b>Salary Range (annually)</b></p>$205,000.00 - $341,600.00</div>

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