Manager, Regulatory Affairs, Advertising & Promotion

Regeneron

Manager of Regulatory Affairs for Advertising and Promotion at Regeneron, managing regulatory activities for advertising compliance in the biotechnology sector.

Posted 6/2/2026full-timeSleepy Hollow • New Jersey, New York • 🇺🇸 United StatesJuniorMid-Level💰 $128,600 - $210,000 per yearWebsite

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Hard Skills

regulatory activitiesadvertising and promotionpromotional material reviewFDA compliancelabeling developmentclinical trial recruitment materialspharmaceutical product developmentbiologics experiencestrategic regulatory adviceglobal promotional review

Soft Skills

communication skillscollaborationprocess improvementcross-functional teamworkrelationship managementcreativityadvisory skillsinfluenceproblem-solvingstakeholder engagement

Tools & Technologies

FDA Form 2253Regulatory AffairsAdvertising & Promotion Directormarketing application summary documentshealth authorities

Certifications & Qualifications

Bachelor's degree in Life SciencesAdvanced Scientific degree (Masters, PharmD, Ph.D)

Industry Keywords

pharmaceutical marketingregulatory guidelinesFDA Office of Prescription Drug Promotion (OPDP)promotional enforcement activitiesdisease awareness programsspeaker programsco-promotioncommercialization objectivesportfolio standardizationregulatory compliance

About the role

Key responsibilities & impact

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 the advise 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.
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 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; in partnership with management, provide guidance to stakeholders with respect to impact of enforcement activities on the company policies.
Ability to identify process improvement for promotional review activities that would enable the 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 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.

Requirements

What you’ll need

A minimum of 2 total years 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 focus in the area of 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 and support 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
Contributes to the influence of cross-functional teams and may interact with senior management

Benefits

Comp & perks

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) for eligible employees