Associate Manager, Regulatory Advertising & Promotion

Regeneron

Associate Manager in Regulatory Affairs focusing on advertising and promotion for biotech company. Overseeing regulatory activities and collaborating with key stakeholders to ensure compliance.

Posted 7/22/2026full-timeSleepy Hollow • New Jersey, New York • 🇺🇸 United StatesJuniorMid-Level💰 $109,900 - $179,300 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory affairs with a focus on advertising and promotion, ensuring compliance with FDA regulations and guidelines. Capable of collaborating cross-functionally to support product messaging and promotional material development.

Highest-signal resume keywords

Regulatory Affairs ExperienceFDA InteractionPromotional Material ReviewAdvanced Scientific DegreePharmaceutical Product Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory ComplianceAdvertising RegulationsPromotional Review ProcessesLabeling DevelopmentScientific Communication

Soft Skills

CollaborationCommunication SkillsProblem-Solving

Industry Keywords

FDA Office of Prescription Drug PromotionForm 2253BiologicsGlobal Promotional ReviewClinical Trial Recruitment Materials

About the role

Key responsibilities & impact

Contribute to the 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
Contribute to advise on the development of product messages and materials across multiple functional areas
Assist with providing 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
Assist with providing 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
Ability to collaborate cross functionally with key stakeholders in areas such as Marketing, Medical Affairs, and Legal
Contributes to the working relationship and managing communication with regulatory advertising and promotion professionals at co-promote partner companies
Assist with interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned company products, assist with 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; help assess the potential impact of enforcement activities on the company policies
Knowledge of process improvement for promotional review activities that would enable the establishment of portfolio wide standardization of policies
Knowledge of products/indications to help provide 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
Knowledge of the input provided during review cycles to reflect commercialization objectives and messages in the submission documents/reports that are submitted to health authorities
Ability to understand and work with management during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising

Requirements

What you’ll need

A minimum of 1 to 2 years within regulatory affairs, preferably within advertising and promotion
Requires advanced scientific degree (i.e., Masters, PharmD, Ph.D) or at minimum, a Bachelor's degree (BS) from an accredited college or university in Life Sciences
Fundamental understanding 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 is highly preferred, biologics experience is a plus
Experience working directly/indirectly with the FDA, specifically OPDP/APLB is desirable
Ability to review promotional materials and interact with FDA OPDP/APLB and help support launch products/campaigns, while maintaining excellent written/verbal communication skill
Familiarity with global promotional review, clinical trial recruitment materials, and labeling regulations is desirable

Benefits

Comp & perks

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
family support benefits