Associate Manager (Pharma Regulatory Affairs)

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

Salary: $109,900–$179,300 annually

Company

hirify.global is a science-driven biotechnology company developing medicines for people with serious diseases.

What you will do

• Support US regulatory activities for advertising and promotion of marketed pharmaceutical products.
• Help develop and review product messages and promotional materials across Commercial, Medical Affairs, Marketing, and Legal functions.
• Support conference exhibits, disease-awareness initiatives, speaker programs, clinical trial recruitment materials, and global communications.
• Assist with interactions with the FDA Office of Prescription Drug Promotion and promotional material submissions on Form 2253.
• Monitor evolving regulatory requirements and FDA promotional enforcement activity, assessing potential impacts on company policies and product teams.
• Support labeling development, marketing application reviews, process improvement, and communication with co-promotion partners.

Requirements

• 1–2 years of experience in Regulatory Affairs, preferably in advertising and promotion, or a relevant post-doctoral fellowship.
• Advanced scientific degree such as a Master’s, PharmD, or Ph.D.; a bachelor’s degree in Life Sciences is the minimum requirement.
• Fundamental understanding of pharmaceutical product development, marketing regulations, guidelines, and advertising and promotion precedents.
• Experience reviewing promotional materials and supporting product or campaign launches with strong written and verbal communication skills.
• Ability to collaborate with cross-functional teams and interact with senior management.
• Ability to work on site four days per week in Sleepy Hollow, NY, or Warren, NJ.

Nice to have

• Experience with pharmaceutical products; biologics experience is a plus.
• Direct or indirect experience working with the FDA, particularly OPDP or APLB.
• Familiarity with global promotional review, clinical trial recruitment materials, and labeling regulations.

Culture & Benefits

• Science-driven work focused on developing life-changing medicines.
• Inclusive culture and equal employment opportunity.
• Potential benefits include bonuses or incentive plans, equity awards, retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.
• Reasonable accommodations are provided during the recruitment process where required.