Senior Program Director, Commercial Regulatory Affairs

Responsibilities

• Lead Promotional Review Committee (PRC) meetings
• Review and approve promotional and marketing materials
• Provide regulatory guidance on advertising and promotional claims
• Partner with Marketing, Medical, Legal, and Compliance teams
• Support FDA communications and Form 2253 submissions
• Ensure compliance with FDA regulations and healthcare industry guidelines

Requirements

• Bachelor's degree required; advanced degree (PharmD, PhD, JD, MBA, MS) preferred
• 7+ years of Regulatory Affairs, Commercial Regulatory, Compliance, or Advertising & Promotion experience in the biotech/pharmaceutical industry
• Strong knowledge of FDA advertising & promotion regulations, promotional review, and healthcare compliance
• Experience leading cross-functional teams and Promotional Review Committees (PRCs)
• Excellent communication, stakeholder management, and project leadership skills.

Core Competencies

Demonstrates expertise in Regulatory Affairs and Compliance within the biotech and pharmaceutical industries, with a strong focus on FDA advertising and promotion regulations. Proven ability to lead cross-functional teams and manage promotional review processes effectively.