Senior Manager, Regulatory Affairs, Advertising & Promotion

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

Company

hirify.global is a biotechnology company that develops and commercializes medicines for serious diseases, including cancer, cardiovascular and metabolic diseases, neurological diseases, infectious diseases, and rare diseases.

What you will do

• Manage US and applicable global regulatory activities for advertising and promotion of marketed products and pipeline products.
• Advise Commercial and Medical Affairs teams on product messaging, conference exhibits, disease awareness initiatives, speaker programs, and promotional materials.
• Review product and disease-state communications for compliance with applicable laws, regulations, and guidance.
• 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 stakeholders on their impact.
• Contribute to process improvement, portfolio-wide policy standardization, labeling development, and health authority submission reviews.

Requirements

• 3–4 years of experience in regulatory affairs, preferably in advertising and promotion.
• Bachelor’s degree in life sciences or equivalent regulatory experience; an advanced medical or science degree is preferred.
• Advanced knowledge of pharmaceutical product development, marketing regulations, guidelines, and precedents, with a focus on advertising and promotion.
• Pharmaceutical product experience is required; biologics experience is advantageous.
• Experience working with the FDA, particularly OPDP/APLB, and reviewing promotional materials.
• Strong written and verbal communication skills, with the ability to influence cross-functional teams and advise senior stakeholders.

Nice to have

• Experience supporting global promotional review.
• Understanding of clinical trial recruitment materials and labeling regulations.

Culture & Benefits

• Inclusive workplace and equal opportunity employment.
• Competitive total rewards package, potentially including annual bonuses, equity awards, retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.
• 401(k) company match may be available for US employees.
• Roles are generally expected to be performed onsite to support collaboration.