Senior Program Director (Commercial Regulatory Affairs, Fully Remote)

Dawar Consulting • South San Francisco, CA

43d • Remote

About The Position

In this role, you will provide strategic regulatory guidance for U.S. commercial pharmaceutical products. You will lead Promotional Review Committees (PRCs), review and approve advertising and promotional materials, and partner closely with Marketing, Medical Affairs, Legal, and Compliance to ensure FDA‑compliant communications. This position offers the opportunity to shape commercial regulatory strategy for innovative therapies in a fast‑paced biotech environment.

Requirements

• Bachelor's degree required
• 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

Nice To Haves

• Advanced degree (PharmD, PhD, JD, MBA, MS) preferred
• Commercial Regulatory Affairs
• Advertising & Promotion (Ad/Promo)
• Promotional Review Committee (PRC)
• FDA Form 2253
• Medical, Legal, Regulatory (MLR) review
• Product launch support

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

Benefits

• Medical
• Dental
• Vision
• Paid Sick Leave
• 401K

What This Job Offers

• Job Type: Full-time
• Career Level: Senior