Manager, Regulatory Affairs, Advertising & Promotion

Location: Sleepy Hollow, New York or Warren, New Jersey; 4 days per week onsite

Salary: $128,600–$210,000 annually

Company

hirify.global develops medicines for people with serious diseases through science and innovation.

What you will do

• Manage US regulatory advertising and promotion activities for marketed pharmaceutical products.
• Develop and review product messages, promotional materials, disease-state communications, conference exhibits, and speaker programs.
• Provide regulatory advice to Commercial, Medical Affairs, Marketing, Legal, and other cross-functional stakeholders.
• Support interactions with the FDA Office of Prescription Drug Promotion, including advisory submissions and Form 2253 promotional material submissions.
• Monitor regulatory requirements and FDA promotional enforcement activity, advising product teams on their impact.
• Support labeling, marketing application, study report, and commercialization reviews while identifying opportunities to standardize promotional review processes.

Requirements

• At least 2 years of relevant experience, preferably in Regulatory Advertising and Promotion.
• Bachelor’s degree in Life Sciences from an accredited college or university.
• Knowledge of regulations, guidelines, and precedents related to pharmaceutical product development, marketing, advertising, and promotion.
• Experience with pharmaceutical products and the ability to review promotional materials and provide strategic regulatory advice.
• Strong written and verbal communication skills and the ability to collaborate with cross-functional teams and senior management.
• Ability to work onsite 4 days per week in Sleepy Hollow, NY or Warren, NJ.

Nice to have

• Advanced scientific degree such as a Master’s, PharmD, or PhD.
• Biologics experience.
• Direct or indirect experience with FDA OPDP/APLB.
• Experience supporting global promotional review, clinical trial recruitment materials, or labeling regulations.

Culture & Benefits

• Science-driven environment focused on developing life-changing medicines.
• Inclusive workplace and equal employment opportunity.
• Potential benefits include bonuses, equity awards, retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.
• Onsite collaboration is emphasized for many roles.