About CG Oncology, Inc.
Are you ready to make a difference in the world and become part of our patient-centered team that is focused on Attacking Bladder Cancer for a Better Tomorrow? At CG Oncology, we believe that by having exceptionally talented individuals on our team who share our passion and enjoy working together, we can truly achieve our Vision and Mission to benefit patients around the world.
Every day we are making significant advancements across our multiple pipelines and are growing rapidly to meet the needs of our patients who cannot afford to wait to benefit from our novel immunotherapies. Please review this job posting and our Values and if they resonate with you and are what you expect from your organization and team, then we would like to hear from you.
About the role
The Director of Regulatory Affairs reports to the Vice President of Regulatory Affairs and is responsible for leading regulatory strategy and execution across promotional and labeling review including broader regulatory activities. This role will serve as the regulatory lead supporting CG Oncology's transition to commercialization and will play a critical role in promotional review, labeling strategy, launch readiness, MLR governance, and lifecycle regulatory support. This role plays a critical leadership function in ensuring that all promotional and labeling materials and external communications are accurate, compliant, and aligned with FDA regulations, PhRMA guidelines, and company policies.
This individual will partner closely with Commercial, Marketing, Medical, Legal, and Compliance teams to provide strategic regulatory guidance on promotional content, claims, and communication strategies. The Director will also support regulatory submissions, agency interactions, and lifecycle management activities, contributing to the advancement and commercialization of CG Oncology’s pipeline.
Essential Functions
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Lead regulatory review of promotional material, labeling, and external communications intended for healthcare professionals (HCPs), patients, and caregivers, ensuring content is accurate, balanced, and compliant with FDA regulations, PhRMA principles, and company policies
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Provide authoritative regulatory guidance on promotional content, including evaluating claims and developing compliant strategies in collaboration with Commercial, Medical, Legal, and other cross-functional teams
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Ensure all promotional materials are consistent with FDA-approved labeling and aligned with regulatory expectations
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Oversee timely and accurate submission of promotional materials to the FDA using Form 2253
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Establish, enhance, and streamline regulatory review processes, including SOPs and workflows, to improve efficiency, consistency, and compliance
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Act as a regulatory subject-matter expert in cross-functional meetings, ensuring alignment between regulatory requirements and business objectives
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Partner with clinical development, CMC, quality, and medical affairs teams to support regulatory strategy across the product lifecycle
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Provide regulatory guidance on scientific exchange, medical education, investigator communications, and disease awareness initiatives
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Monitor and interpret evolving regulatory requirements and guidance, proactively advising internal stakeholders on potential impacts
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Support regulatory agency interactions, including preparation of briefing documents and responses to health authority inquiries regarding label content
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Contribute to lifecycle management strategies, including label updates and post-marketing regulatory requirements
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Develop and implement SOPs, work instructions, and training programs for promotional review and labeling governance
Qualifications
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Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred.
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10+ years of regulatory affairs experience in the pharmaceutical or biotechnology industry.
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5+ years of experience in promotional regulatory review and advertising/promotion compliance.
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Deep understanding of FDA regulations, guidance, and PhRMA principles related to promotional materials.
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Experience with FDA Form 2253 submissions and promotional review processes.
Please note that CG Oncology does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Any resumes or client information submitted to our careers page or any employee of CG Oncology by any search firm or agency without an applicable contract in place will become the property of CG Oncology and no fee(s) will be paid.
Total Rewards
CG Oncology offers very competitive and comprehensive Total Rewards, helping to support and reward our global team of high-performing employees focused on developing bladder-saving therapeutics for patients afflicted with bladder cancer.
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HIGHLY COMPETITIVE SALARIES
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ANNUAL PERFORMANCE/MERIT REVIEWS
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ANNUAL PERFORMANCE BONUSES
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EQUITY
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SPECIAL RECOGNITION
Well-Being Benefits
In addition to our Total Rewards, CG Oncology offers a variety of Well-Being Benefits to meet the majority of the needs of our unique and growing workforce. These benefits are designed to support our team to achieve a healthy balance between work and their personal lives to remain refreshed, engaged, and creating an environment where each person can find a deeper meaning and purpose in their work.
Well-Being Benefits eligibility begins the 1st of the month after hire. While a majority of these benefits are for our US-based workforce, we continue to assess comparable levels of benefits for our international team members that are aligned with country-specific regulations and their national programs offered.
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FULLY REMOTE WORK ENVIRONMENT
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REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off
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HOLIDAYS –In 2026 we will observe 14 holidays
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RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary
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HEALTH (MEDICAL, DENTAL, VISION) – PPO & HDHP – Cigna/Principal
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HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC
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ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans
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LIFE INSURANCE – Company Paid 1 x base salary + Voluntary Plans
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ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More
CG Oncology is an Equal Opportunity Employer:
All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. At CG Oncology, we are building a community of intelligent and passionate team members that share our Vision, Mission and Values, and while the biotechnology space can feel limited in BIPOC, non-binary and even female representation, we endeavor to make hiring decisions that will continue to grow and support our team in the direction of maintaining cultural diversity and sustainability.
