Senior Manager, Regulatory Affairs, Advertising & Promotion

About the role

We are seeking a Senior Manager to join our Regulatory Affairs Advertising and Promotion team. This position requires the ability to apply clinical development knowledge in concert with experienced understanding of advertising and promotion regulations/guidance to the development of key product messages presented in Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs). The Senior Manager will provide regulatory advertising and promotion expertise to relevant stakeholders, typically carrying out responsibilities with minimal guidance from the Regulatory Affairs, Advertising and Promotion Director.

The Senior Manager Regulatory Affairs, Advertising and Promotion will oversee therapeutic area(s) and ensure that messages are translated into advertising and promotion initiatives that meet commercial teams' objectives while maintaining compliance and corporate integrity.

Work Location: Sleepy Hollow, NY or Warren, NJ
Hybrid: 4 days per week on site

Responsibilities

• Manage 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.
• Oversee commercial activities from a regulatory advertising and promotion perspective with minimal guidance from the Regulatory Affairs, Advertising & Promotion Director.
• Creatively advise on 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 (if applicable) 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 Marketing, Medical Affairs, and Legal.
• 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 company products, maintaining effective communication with FDA OPDP reviewers on advertising and promotion matters, including 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.
• Provide input on process improvement for promotional review activities and portfolio-wide standardization of policies.
• Cross-train across products/indications 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.
• Provide input during review cycles to reflect commercialization objectives and messages in submission documents/reports submitted to health authorities.
• Provide input to management during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising.

Requirements

• 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, PharmD, Ph.D., MD, or DO) preferred in the field of medicine or science. Regulatory experience can offset education requirements.
• Advanced 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/indirectly with the FDA, specifically OPDP/APLB, is preferred.
• Ability to review promotional materials, interact with FDA OPDP/APLB, and manage launch products/campaigns while maintaining excellent written/verbal communication skills when providing 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

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g., medical, dental, vision, life, and disability), paid time off, and family support benefits.

Pay

Salary Range (annually): $150,500.00 - $245,500.00