Director, Regulatory Affairs - Advertising & Promotion (Biotech)

TL;DR

Director, Regulatory Affairs - Advertising & Promotion (Biotech): Providing strategic regulatory guidance and review for promotional and non-promotional materials to ensure compliance with FDA regulations and company policies. Focus on leading MLR review committees, managing OPDP interactions, interpreting enforcement trends, and optimizing review processes for high-impact promotional activities.

Location: Concord, MA

Salary: $215,000-$240,000 annually

Company

hirify.global develops innovative therapies for rare disease communities with urgency, ambition, and compassion.

What you will do

• Review, approve, and provide regulatory guidance on promotional, corporate, and non-promotional materials for compliance.
• Represent regulatory perspective in promotional review committees (MLR) with Marketing, Medical Affairs, Legal, and Compliance.
• Lead discussions to reach consensus on materials and manage OPDP interactions including advisory comments and FDA Form 2253 submissions.
• Monitor regulations, enforcement trends, and label updates; provide training and strategic input on US labeling.
• Align communication with Medical, Marketing, Regulatory, Legal teams and optimize PRC processes and workflows.

Requirements

• Willingness to travel to various meetings or sites, including overnight trips
• Bachelor’s degree in life sciences, pharmacy, regulatory affairs, or related; advanced degree preferred
• 8-10+ years progressive Regulatory Affairs experience in biotech/pharma; 5+ years in prescription drug advertising/promotion review
• Experience with OPDP, advisory comments, FDA Form 2253, reviewing digital/traditional promotional materials
• Ability to interpret clinical data, knowledge of study design/statistics for promotional claims
• Strong regulatory judgment, communication, influence, cross-functional collaboration in fast-paced environment

Culture & Benefits

• Collaborative environment partnering across Medical, Legal, Marketing, and commercial teams
• Focus on advancing mission for rare disease communities
• Compensation based on skills, experience, location, and internal equity