Manager, Regulatory Affairs, Advertising & Promotion

Regeneron is seeking a Manager, of Advertising and Promotion to join our Regulatory Affairs team!! Responsibilities Management of US regulatory activities associated with advertising and promotion of the company’s marketed products. Manages commercial activities from a regulatory advertising and promotion perspective with guidance from the Regulatory Affairs, Advertising & Promotion Director. Creatively contribute to advising on the development of product messages and materials across multiple functional areas. Provide timely regulatory advice and guidance to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs. Provide review of US and Global product and disease state materials/communications, to support corporate goals and comply with applicable laws, regulations, and guidance. Collaborate cross‑functionally with key stakeholders in areas such as Marketing, Medical Affairs, and Legal. Establish 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 company products, maintaining effective communication with FDA OPDP reviewers concerning advertising and promotion matters, including requests for advisory submissions. Ensure compliance with promotional material submissions to FDA on Form 2253. Monitor the external environment to 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 activities on company policies. Identify process improvements for promotional review activities that enable portfolio‑wide standardization of policies. Cross‑train across products/inductions to ensure continuous Regulatory A&P support is provided to stakeholders. Collaborate with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports. Assist in review cycles to reflect commercialization objectives and messages in the submission documents/reports submitted to health authorities. Provide input during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising. Qualifications A minimum of 2 years of relevant experience, preferably within Regulatory Advertising and Promotion. At least a Bachelor’s degree in Life Sciences; an advanced scientific degree (e.g., Master’s, PharmD, Ph.D.) preferred. Knowledge of regulations, guidelines, and precedents related to pharmaceutical product development and marketing, with a focus 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 to support launch products/campaigns, while maintaining excellent written and verbal communication skills when giving strategic regulatory advice. Ability to support global promotional review, understanding of clinical trial recruitment materials, and familiarity with labeling regulations desirable. Contribute to influencing cross‑functional teams and may interact with senior management. Benefits Regeneron provides comprehensive benefits that vary by location. In the U.S., benefits may include health and wellness programs (including 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. For additional information about Regeneron benefits in the U.S., please visit For other countries, specific benefits can be discussed with your recruiter. Location & On‑site Policy Please be advised that, at Regeneron, many roles are required to be performed on‑site. For more information about Regeneron’s on‑site policy and expectations for your role and location, please speak with your recruiter and hiring manager. EEO Statement Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national 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 status, 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. Background Checks Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, and will include verification of identity, right to work, educational qualifications, and other relevant information. Salary Salary Range (annually) : $128,600.00 - $210,000.00 #J-18808-Ljbffr Initial Therapeutics, Inc.