Associate Director/Director, Regulatory Affairs Advertising & Promotions

Location: Hybrid role requiring candidates to work the majority of the week in the Monmouth Junction, New Jersey office, United States.

Salary: Associate Director — $160,000–$180,000 per year; Director — $185,000–$230,000 per year.

Company

hirify.global is a privately owned US biopharmaceutical company developing and commercializing medicines for ADHD, spectrum disorders, anxiety, pain, addiction, and other therapeutic areas.

What you will do

• Review and approve advertising, promotional materials, and external communications for compliance with FDA laws, regulations, guidance, approved labeling, industry standards, and company policies.
• Provide strategic regulatory advice for compliant and competitive advertising and promotional initiatives.
• Serve as a regulatory resource for promotional activities and communicate new FDA regulations, guidance, and enforcement actions to the Promotional Review Committee and senior management.
• Prepare and approve Form FDA-2253 submissions to the FDA Office of Prescription Drug Promotion.
• Provide training on FDA expectations for advertising and promotion and support claim substantiation strategies.
• Drive improvements to advertising and promotion regulatory review processes.

Requirements

• Associate Director: PhD or PharmD in life sciences, pharmacy, medicine, or a related discipline with at least 3 years of relevant regulatory review experience, or a bachelor's degree with at least 7 years of experience.
• Director: PhD or PharmD with at least 4 years of relevant regulatory review experience, or a bachelor's degree with at least 8 years of experience.
• In-depth knowledge of FDA regulations and their interpretation for prescription drug advertising, promotion, and labeling.
• Direct experience interacting with the FDA Office of Prescription Drug Promotion.
• Ability to influence without direct authority.
• Ability to work the majority of the week from the Monmouth Junction, NJ office in a hybrid arrangement.

Culture & Benefits

• Bonus eligibility and competitive compensation.
• Medical, dental, vision, and prescription drug insurance.
• 401(k) plan with company match and life insurance.
• Paid company holidays, paid time off, and paid volunteer time.
• Employee Resource Groups and an equal opportunity workplace.