Senior Program Director, Commercial Regulatory Affairs

This is a fully remote position, open to applicants in California.

📋 Description

• Facilitate meetings for the Promotional Review Committee (PRC)

• Evaluate and authorize promotional and marketing materials

• Offer regulatory insights regarding advertising and promotional claims

• Collaborate with Marketing, Medical, Legal, and Compliance departments

• Assist with FDA communications and Form 2253 submissions

• Ensure adherence to FDA regulations and guidelines within the healthcare industry

⛳️ Requirements

• Bachelor's degree is mandatory; advanced degree (PharmD, PhD, JD, MBA, MS) is preferred

• Over 7 years of experience in Regulatory Affairs, Commercial Regulatory, Compliance, or Advertising & Promotion within the biotech/pharmaceutical sector

• Comprehensive understanding of FDA advertising & promotion regulations, promotional review processes, and healthcare compliance

• Proven experience in leading cross-functional teams and Promotional Review Committees (PRCs)

• Exceptional communication, stakeholder management, and project leadership abilities.

🏝️ Benefits

• Medical

• Dental

• Vision

• Paid Sick Leave

• 401K