Manager, Regulatory Affairs; CMC & Clinical

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.

The Manager, Regulatory Affairs will support the development and execution of regulatory strategies for assigned programs, with a balanced focus on CMC and Clinical Regulatory Affairs. This role will serve as a key regulatory contributor on cross‑functional project teams and support interactions with U.S. and global health authorities under the direction of senior regulatory leadership. The position emphasizes hands‑on regulatory execution, document preparation, and cross‑functional coordination across clinical development and CMC activities from IND through early commercialization.

Remote

• Regulatory Strategy Support
  • Contribute to regulatory strategy development for assigned programs under the guidance of senior regulatory leadership.
  • Identify and communicate regulatory considerations, risks, and mitigation strategies related to CMC and Clinical activities in a phase‑appropriate manner.
  • Support global regulatory planning across development stages (IND through post‑approval).
• Regulatory Submissions & Documentation
  • Draft, review, and coordinate regulatory documents for submissions including INDs, IND amendments, annual reports, briefing documents, IBs, and responses to health authority requests.
  • Support the preparation of clinical and CMC sections of regulatory submissions ensuring accuracy, clarity, and compliance with applicable regulations (FDA, EMA, ICH).
  • Ensure regulatory documents meet quality, formatting, and submission readiness standards.
• CMC & Clinical Regulatory Support
  • Provide regulatory input to CMC teams related to manufacturing changes, comparability, specifications, and lifecycle management.
  • Review clinical documents including protocols, ICFs, CSRs, DSURs, and study plans to ensure regulatory compliance.
  • Support alignment between clinical development plans and CMC readiness.
• Cross‑Functional Collaboration
  • Act as a regulatory representative on project teams, working closely with Clinical Development, CMC, Quality, Nonclinical, and Regulatory Operations.
  • Coordinate regulatory activities and timelines to support development milestones.
  • Prepare internal regulatory updates and contribute to team presentations as needed.
• Health Authority Interaction Support
  • Support preparation for health authority meetings, including briefing packages and Q&A documents.
  • Participate in agency communications as appropriate, under the direction of senior regulatory leadership.
• Compliance & Quality
  • Ensure compliance and regulatory obligations are handled in accordance with SOPs and applicable regulations.
  • Maintain up‑to‑date knowledge of regulatory guidelines and industry trends relevant to CMC and clinical development.

• Bachelor’s degree in a scientific or related discipline.
• Five (5) years of regulatory affairs experience in pharmaceutical or biotechnology development.
• Demonstrated experience supporting IND‑stage and/or clinical development programs.
• Experience drafting regulatory documents and supporting regulatory submissions.
• Working knowledge of CMC and clinical regulatory requirements.
• Familiarity with eCTD structure and regulatory documentation standards.

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…