Impress employers and recruiters.
Choose from hundreds of resume examples.

Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

About the Role

Provide strategic regulatory guidance for U.S. commercial pharmaceutical products, lead Promotional Review Committees (PRCs), and review/approve advertising and promotional materials. Partner closely with Marketing, Medical Affairs, Legal, and Compliance to ensure FDA-compliant communications. Shape commercial regulatory strategy for innovative therapies in a fast-paced biotech environment.

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

• 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)

Skills

• Commercial Regulatory Affairs
• Advertising & Promotion (Ad/Promo)
• Promotional Review Committee (PRC)
• FDA Form 2253
• Medical, Legal, Regulatory (MLR) review
• Product launch support
• Excellent communication
• Stakeholder management
• Project leadership skills

Location

• South San Francisco, CA

Work Type

• Fully Remote
• Long-Term Contract

Experience Level

• Senior

Education Level

• Bachelor's degree required
• Advanced degree (PharmD, PhD, JD, MBA, MS) preferred

Salary/Compensations

• $120-$127/hr on W2

Benefits

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

About the Company

• Our client is a world leader in biotechnology and life sciences.