Manager, Regulatory Affairs, Advertising & Promotion

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

Company

hirify.global is a biotechnology company that discovers, develops, and commercializes medicines for serious diseases.

What you will do

• Manage US regulatory activities related to advertising and promotion of marketed pharmaceutical products.
• Provide regulatory advice on product messages, promotional materials, conference exhibits, disease awareness initiatives, and speaker programs.
• Review US and applicable global product and disease-state communications for compliance with laws, regulations, and guidance.
• Collaborate with Marketing, Medical Affairs, Legal, co-promotion partners, and other cross-functional stakeholders.
• Support interactions with FDA OPDP/APLB reviewers, including advisory submissions and promotional material submissions on Form 2253.
• Monitor evolving regulatory requirements and enforcement activity, while supporting labeling, marketing application, and study report reviews.

Requirements

• At least 2 years of relevant experience, preferably in Regulatory Affairs Advertising and Promotion.
• Bachelor’s degree in Life Sciences from an accredited college or university.
• Knowledge of regulations, guidelines, and precedents related to pharmaceutical development, marketing, advertising, and promotion.
• Pharmaceutical product experience is required; biologics experience is advantageous.
• Ability to review promotional materials and provide clear written and verbal strategic regulatory advice.
• Experience with FDA OPDP/APLB, global promotional review, clinical trial recruitment materials, or labeling regulations is desirable.

Culture & Benefits

• Work in a science-driven biotechnology organization focused on medicines for serious diseases.
• Comprehensive rewards may include bonuses, equity awards, retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.
• Inclusive workplace and equal opportunity employment practices.
• Reasonable accommodation is available during recruitment where required.