Manager, Regulatory Affairs, Advertising & Promotion

Build our future together at Regeneron, where we use science and innovation to develop life-changing medicines for people with serious diseases.

About the role

In this role, you will apply clinical development knowledge in concert with experienced understanding of advertising and promotion regulations/guidances to the development of key product messages presented in Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs). This individual will provide regulatory advertising and promotion expertise to relevant stakeholders, typically carrying out responsibilities with guidance from the Regulatory Affairs, Advertising and Promotion Director.

The Manager Regulatory Affairs, Advertising and Promotion will oversee therapeutic area(s) and ensure that messages are translated into advertising and promotion initiatives that meet the commercial team’s objectives, while maintaining the necessary state of compliance and corporate integrity. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

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

Responsibilities

• Manage US regulatory activities associated with advertising and promotion of the company’s marketed products.
• Manage commercial activities from a regulatory advertising and promotion perspective with guidance from the Regulatory Affairs, Advertising & Promotion Director.
• Creatively contribute to the advice on the development of product messages and materials across multiple functional areas.
• Provide timely regulatory advice and guidance, with 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 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.
• Establish working relationships and manage 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; maintain working relationships and effective communication with FDA OPDP reviewers regarding 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 with respect to FDA promotional enforcement activities; provide stakeholders with regular updates and, in partnership with management, guidance on the impact of enforcement activities 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 is provided to stakeholders.
• Collaborate with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports.
• With guidance from management, help 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 2 total years of relevant experience, preferably within Regulatory Advertising and Promotion.
• At minimum, a Bachelor's degree (BS) from an accredited college or university in Life Sciences. An advanced scientific degree (i.e., Masters, PharmD, Ph.D.) is 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/indirectly with the FDA, specifically OPDP/APLB, is preferred.
• Ability to review promotional materials and interact with FDA OPDP/APLB, supporting launch products/campaigns while maintaining excellent written/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 is desirable.
• Contributes to the influence of cross-functional teams and may 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.

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Pay

Salary Range (annually): $128,600.00 - $210,000.00

Schedule

Hybrid: 4 days per week on site