Director, Regulatory Strategy

CG Oncology, Inc.; United States; Remote; USD 180,000 - 320,000; Full time

Benefits offered by this job

Fully remote work environment

Annual bonuses

401(k) with company match

Job summary

CG Oncology, Inc. seeks a seasoned Director of Regulatory Strategy to guide regulatory planning for its lead asset, Cretostimogene grenadenorepvec, across global opportunities. The role requires deep oncology regulatory expertise and a track record of successful submissions.

The candidate will lead cross-functional teams, interact with global health authorities, and shape submission strategies from early development through product designation and approvals.

Qualifications

• Minimum of twelve (12) years of regulatory affairs experience in the pharmaceutical/biotechnology industry, with a focus on oncology required.
• Master's degree in life sciences, pharmacy or related field required; PhD preferred.
• Proven track record of leading successful regulatory submissions and achieving market approvals.
• Extensive experience in developing regulatory strategies and managing regulatory submissions for investigational drugs and biologics.
• Strong knowledge of international regulations and guidelines, including experience with BLA/MAA submissions.
• Excellent leadership and team management skills.
• Exceptional communication, negotiation, and interpersonal skills.
• Ability to work effectively in a fast-paced and dynamic environment.

Responsibilities

• Provide strategic advice on integrated regulatory development plans for the clinical development of lead assets.
• Lead regulatory submissions and ensure alignment with company objectives and regulatory requirements.
• Serve as RA representative on project teams and drive innovative regulatory approaches.
• Develop strategies for Fast Track and Breakthrough Therapy designations and RMAT where applicable.
• Author and review regulatory documents including INDs/CTA, BLA/MAA submissions and regulatory meetings.
• Ensure high-quality regulatory submissions meeting all guidelines and requirements.
• Monitor regulatory trends and provide intelligence to inform strategy.
• Support oncology clinical development strategies and study design.

Skills

Regulatory strategy

Regulatory submissions

Leadership

Cross-functional leadership

Clinical development

Immunology/Oncology knowledge

Education

Master's degree in life sciences

PhD preferred

Tools

IND/CTA submissions

BLA/MAA submissions

Job description

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.

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

CG Oncology is seeking a highly experienced Director of Regulatory Strategy to support the clinical development of our lead asset, Cretostimogene grenadenorepvec. The ideal candidate will bring a robust medical and scientific background in Regulatory Affairs, particularly within oncology, and a proven track record of successfully navigating regulatory pathways and articulating regulatory strategy based on the international regulatory landscape. This role demands strategic vision, operational excellence, authoring capabilities and collaboration skills.

Essential Functions

Regulatory Strategy and Submission Leadership

• Provide strategic advice on integrated regulatory development plans to expend the clinical development of Cretostimogene grenadenorepvec.
• Provide strategic direction for regulatory submissions, ensuring alignment with company objectives and regulatory requirements.
• Serve as the Regulatory Affairs representative on assigned project teams and assure the progress of projects an effective and innovative regulatory approach best suited for the program.
• Utilize extensive experience in developing strategies for product designations such as Fast Track (FT), and Breakthrough Therapy (BDT).
• Assist in authoring, review, and submission of regulatory documents including INDs/CTA, BLAs/MAA/NDS, Meeting package, iPSP, FT, BDT, RMAT (and equivalent outside of the U.S.) and other necessary filings.
• Ensure all regulatory submissions meet the highest quality standards and regulatory requirements.
• Provide quality assurance to ensure compliance with all applicable regulations and guidelines.
• Monitor the competitive landscape to identify regulatory trends, new guidelines, and competitor strategies.
• Provide regulatory intelligence to inform strategic decision-making.
• Support clinical development strategies for oncology, including study design.
• Provide support to the clinical team to author clinical study protocols, ensuring alignment with regulatory requirements.
• Apply extensive scientific background, preferably in immunology and oncology to inform regulatory strategies and submissions.

Cross-Functional Leadership and Process Improvement

• Foster a collaborative and high-performance team environment.
• Demonstrates effective leadership in managing cross-functional teams and complex projects.
• Contribute to interactions with global health authorities such as the FDA, EMA, and other regulatory bodies.
• Prepare for and participate in regulatory meetings, including storyboarding and regulatory review processes.

Qualifications

• Minimum of twelve (12) years of regulatory affairs experience in the pharmaceutical/biotechnology industry, with a focus on oncology required.
• Master's degree in life sciences, pharmacy or related field required; PhD in life sciences, pharmacy or related field preferred.
• Proven track record of leading successful regulatory submissions and achieving market approvals.
• Extensive experience in developing regulatory strategies and managing regulatory submissions for investigational drugs and biologics.
• Strong knowledge of international regulations and guidelines, including experience with BLA/MAA submissions.
• Excellent leadership and team management skills.
• Exceptional communication, negotiation, and interpersonal skills.
• Ability to work effectively in a fast-paced and dynamic environment.

Work Authorization for US Applicants

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

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.

• HIGHLY COMPETITIVE SALARIES
• ANNUAL PERFORMANCE/MERIT REVIEWS
• ANNUAL PERFORMANCE BONUSES
• EQUITYSPECIAL 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.

• FULLY REMOTE WORK ENVIRONMENT
• REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off
• HOLIDAYS - In 2026 we will observe 14 holidays
• RETIREMENT - 401K with 100% company Safe Harbor match up to 4% of base salary
• HEALTH (MEDICAL, DENTAL, VISION) - PPO & HDHP - Cigna/Principal
• HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC
• ILLNESS & DISABILITY PROTECTION - Company Paid LTD Coverage + Voluntary Plans
• LIFE INSURANCE - Company Paid 2 x base salary + Voluntary Plans
• 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.