Entry Level Regulatory Advertising Promotion Jobs

We are seeking a Manager to join our Regulatory Affairs Advertising and Promotion team. The role focuses on ensuring that product messages for biologic drug products are compliant with U.S. regulatory requirements while supporting commercial objectives. The position is based in Sleepy Hollow, NY or Warren, NJ with a hybrid model of 4 days on site.

• Manage U.S. regulatory activities related to the advertising and promotion of marketed products.
• Provide timely regulatory advice and guidance to commercial teams and Medical Affairs on conference exhibit activities, disease-awareness efforts, and speaker programs.
• Review U.S. and global product and disease-state materials/communications to ensure compliance with applicable laws, regulations, and guidance.
• Collaborate cross‑functionally with Marketing, Medical Affairs, Legal, and other stakeholders.
• Establish and maintain working relationships with regulatory advertising and promotion professionals at co‑promote partner companies.
• Lead interactions with the FDA Office of Prescription Drug Promotion (OPDP) for assigned company products, including advising on advisory submissions.
• Ensure compliance with promotional material submissions to the FDA on Form2253.
• Monitor the external environment and advise product teams on evolving regulatory requirements related to product and disease‑state communications.
• Maintain vigilance regarding FDA promotional enforcement activities; provide stakeholders with regular updates and guidance on the impact of enforcement on company policies.
• Identify process improvements for promotional review activities to enable portfolio‑wide standardization of policies.
• Cross‑train across products/indications to provide continuous regulatory A&P support to stakeholders.
• Collaborate with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports and provide input during review cycles to reflect commercialization objectives.
• Provide input during labeling development and negotiation to ensure messages that impact promotion and advertising are appropriately represented.

• Minimum of 2 years of relevant experience, preferably within Regulatory Advertising and Promotion.
• Bachelor’s degree (BS) in Life Sciences; an advanced scientific degree (Masters, PharmD, Ph.D.) is preferred.
• Knowledge of regulations, guidelines, and precedents related to pharmaceutical product development and marketing, focused on advertising and promotion.
• Experience with pharmaceutical products; biologics experience is a plus.
• Experience working directly or indirectly with the FDA, specifically OPDP/APLB.
• Proficiency in reviewing promotional materials and interacting with FDA OPDP/APLB to support launch products/campaigns.
• Excellent written and verbal communication skills, capable of providing strategic regulatory advice.
• Desire to support global promotional review, understand clinical trial recruitment materials, and be familiar with labeling regulations.
• Ability to influence cross‑functional teams and interact with senior management.

• Competitive salary range: $128,600.00 – $210,000.00.
• Annual bonuses or other incentive plans.
• Equity awards, pension or retirement benefits, 401(k) company match.
• Health and wellness programs, fitness centers, and comprehensive insurance benefits (medical, dental, vision, life, and disability).
• Paid time off and family support benefits.

Regeneron is an equal‑opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.