Regulatory Affairs Manager

Regeneron is seeking a Manager, of Advertising and Promotion to join our Regulatory Affairs team!! In this role, a typical day might include applying clinical development knowledge in concert with advertising and promotion regulations or guidance to develop key product messages for Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs). The manager will provide regulatory advertising and promotion expertise to stakeholders, oversee therapeutic areas, and ensure messages translate into commercial initiatives that meet objectives while remaining compliant. Responsibilities Provide regulatory advertising and promotion expertise to relevant stakeholders with guidance from the Director. Oversee therapeutic area(s) and ensure messages translate into advertising and promotion initiatives that meet commercial objectives while maintaining compliance. Manage commercial activities from a regulatory advertising and promotion perspective under guidance from the Director. Contribute creatively to the development of product messages and materials across multiple functional areas. Provide timely regulatory advice and guidance to Commercial teams and Medical Affairs regarding conference exhibit activities, disease awareness, and speaker programs. Review US and Global product and disease‑state materials/communications, supporting corporate goals and compliance with applicable laws, regulations, and guidance. Collaborate cross‑functionally with Marketing, Medical Affairs, and Legal stakeholders. Establish working relationships and manage communication with regulatory advertising and promotion professionals at co‑promote partner companies. Lead and assist in all interactions with the FDA Office of Prescription Drug Promotion (OPDP) for assigned products, maintaining effective communication with FDA reviewers regarding advertising and promotion matters, including advisory submission requests. Ensure compliance with promotional material submissions to FDA on Form 2253. Monitor the external environment and advise product teams on evolving regulatory requirements related to product and disease‑state communications. Provide stakeholder updates on FDA promotional enforcement activities and guidance on 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 ensure continuous Regulatory A&P support to stakeholders. Collaborate with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports. Provide input during review cycles to reflect commercialization objectives and messages in submission documents/reports to health authorities. Contribute to management during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising. Qualifications Minimum of 2 years relevant experience, preferably within Regulatory Advertising and Promotion. At least a Bachelor’s degree (BS) in Life Sciences from an accredited college or university. Advanced Scientific degree (e.g., Master’s, PharmD, Ph.D.) preferred. Knowledge of regulations, guidelines, and precedents related to pharmaceutical product development and marketing, focusing on advertising and promotion. Experience with pharmaceutical products required; biologics experience is a plus. Experience working directly or indirectly with the FDA, specifically OPDP/APLB, preferred. Ability to review promotional materials and interact with FDA OPDP/APLB and support launch products/campaigns. Excellent written and verbal communication skills when providing strategic regulatory advice. Ability 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. Benefits In the U.S., benefits may include health and wellness programs (medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels. Salary range: $128,600.00 – $210,000.00 (annual). For additional information on benefits, visit Equal Employment Opportunity Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business. #J-18808-Ljbffr