Director, Regulatory Affairs - Ad Promo & Labeling

About the role

The Director of Regulatory Affairs leads regulatory strategy and execution across promotional and labeling review, supporting CG Oncology's transition to commercialization. Key responsibilities include:

• Leading regulatory review of promotional material, labeling, and external communications.
• Evaluating claims and developing compliant strategies in collaboration with cross-functional teams.
• Ensuring all promotional materials are consistent with FDA-approved labeling and aligned with regulatory expectations.
• Overseeing timely and accurate submission of promotional materials to the FDA using Form 2253.
• Partnering with various teams to provide strategic regulatory guidance on promotional content, claims, and communication strategies.
• Supporting regulatory submissions, agency interactions, and lifecycle management activities.

Qualifications

• Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred.
• 10+ years of regulatory affairs experience in the pharmaceutical or biotechnology industry.
• 5+ years of experience in promotional regulatory review and advertising/promotion compliance.
• Deep understanding of FDA regulations, guidance, and PhRMA principles related to promotional materials.
• Experience with FDA Form 2253 submissions and promotional review processes.