Senior Manager, Regulatory Affairs, Advertising & Promotion

Role: Senior Manager in Regulatory Affairs Advertising and Promotion at Regeneron, focusing on ensuring compliant and effective promotional activities for marketed and pipeline biologic products. Responsibilities include managing US and global regulatory activities related to advertising, advising cross-functional teams on product messaging, reviewing promotional materials for compliance, and liaising with FDA Office of Prescription Drug Promotion (OPDP). The role involves strategic guidance during labeling, submission review, and promotional campaign development, with oversight of compliance with FDA regulations, including Form 2253 submissions. The candidate will collaborate with Marketing, Medical Affairs, Legal, and external partners to maintain regulatory standards and monitor enforcement activities. Qualifications: 3-4+ years in regulatory affairs, particularly advertising and promotion, with a Bachelor's degree in Life Sciences (advanced degrees preferred). Experience with pharmaceutical/biologics products, FDA interactions, and regulatory guidance is required. Preferred: knowledge of global promotional processes, clinical trial recruitment materials, labeling regulations, and influence with senior management. The position demands excellent communication skills, strategic thinking, and cross-functional influence. Work setup: On-site four days/week in Sleepy Hollow, NY or Warren, NJ, with minimal guidance expected. The role is critical for supporting commercial development of biologics in serious disease areas, ensuring promotional compliance while facilitating product messaging.