Regeneron · 10 hours ago
Senior Manager, Regulatory Affairs Advertising & Promotion
Sleepy Hollow, NY
Full-time
Onsite
Mid, Senior Level
$150K/yr - $246K/yr
3+ years expRegeneron is a biotechnology company focused on developing medicines for serious diseases. They are seeking a Senior Manager in Regulatory Affairs Advertising & Promotion to provide regulatory expertise on advertising and promotion for marketed and pipeline products, ensuring compliance while supporting commercial objectives.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
Management of US and Global (if applicable) regulatory activities associated with advertising and promotion of the company’s marketed products, as well as commercial development of pipeline products
Creatively advise on the development of product messages and materials across multiple functional areas
Provide timely regulatory advice and guidance, with minimal guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs
Provide review of US and Global (if applicable) product and disease state materials/communications, with minimal guidance from Regulatory Affairs, Advertising & Promotion Director, 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
Responsible for establishing working relationship and managing communication with regulatory advertising and promotion professionals at co-promote partner companies
Help lead and assist in all interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned company products, responsible for helping to maintain working relationship and effective communication with FDA OPDP reviewers with respect to advertising and promotion matters, including request for advisory submissions
Responsible for 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 with respect to FDA promotional enforcement activities; provide stakeholders with updates on a regular basis; provide guidance to stakeholders with respect to impact of enforcement activities on the company policies
Provide input to direct management with respect to process improvement for promotional review activities and establishment of portfolio wide standardization of policies
Ability to cross train across products/indications to ensure continuous Regulatory A&P support is provided to stakeholders
Collaboration with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports
With minimal guidance from management, help provide input during review cycles to reflect commercialization objectives and messages in the submission documents/reports that are submitted to health authorities
Provide input to management during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising
Qualification
Required
A minimum of 3 to 4 years within regulatory affairs, preferably within advertising and promotion
At minimum, a Bachelor's degree (BS) from an accredited College or University in Life Sciences. Advanced degree (Masters, Pharm D, Ph.D., MD or DO) preferred in the field of medicine or science. Regulatory experience can offset education requirements
Advance knowledge of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in the area of advertising and promotion
Experience with pharmaceutical products required, biologics experience is a plus
Preferred
Experience working directly/indirectly with the FDA, specifically OPDP/APLB is preferred
Ability to review promotional materials and interact with FDA OPDP/APLB and managing launch products/campaigns, while maintaining excellent written/verbal communication skill when giving strategic regulatory advice
Ability to support global promotional review, understanding of clinical trial recruitment materials, and familiarity with labeling regulations is desirable
Ability to influence cross-functional teams and interact with senior management
Benefits
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
Paid leaves (e.g., military and parental leave)
Company
Regeneron
Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.
10001+ employees
H1B Sponsorship
Regeneron has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (157)
2024 (128)
2023 (128)
2022 (137)
2021 (104)
2020 (122)
Funding
Current Stage
Public CompanyTotal Funding
$15.93MKey Investors
U.S. Department of Health & Human Services
2024-07-11Post Ipo Equity· $2.03M
2023-10-18Post Ipo Equity· $5M
2016-08-22Post Ipo Equity· $8.9M
Leadership Team
Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
Recent News
Pharmaceutical Technology
2026-01-16
2026-01-16
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