Manager, Regulatory Affairs (CMC & Clinical)

The Manager, Regulatory Affairs supports the development and execution of regulatory strategies for CG Oncology's programs, focusing on CMC and Clinical Regulatory Affairs. The role involves regulatory document preparation, cross-functional coordination, and interactions with U.S. and global health authorities, from IND through early commercialization. This is a remote position.

Location: Remote

Salary: $125k–$145k

Responsibilities

• Support regulatory strategy development for assigned programs under guidance of senior regulatory leadership.
• Identify and communicate regulatory considerations, risks, and mitigation strategies related to CMC and Clinical activities.
• Support global regulatory planning across development stages (IND through post-approval).
• Draft, review, and coordinate regulatory documents for submissions including INDs, amendments, reports, briefing documents, IBs, and responses.
• Support preparation of clinical and CMC sections of regulatory submissions ensuring accuracy, clarity, and compliance.
• Provide regulatory input to CMC teams related to manufacturing changes, specifications, and lifecycle management.
• Review clinical documents including protocols, ICFs, CSRs, DSURs, and study plans for regulatory compliance.
• Support alignment between clinical development plans and CMC readiness.
• Act as a regulatory representative on project teams, working 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.
• Support preparation for health authority meetings, including briefing packages and Q&A documents.
• Participate in agency communications under senior regulatory leadership.
• Ensure compliance with SOPs and regulations, maintaining up-to-date knowledge of regulatory guidelines.

Requirements

• Bachelor’s degree in a scientific or related discipline.
• Five (5) years of regulatory affairs experience in pharmaceutical or biotechnology development.
• 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 documentation standards.

Benefits

• HIGHLY COMPETITIVE SALARIES
• ANNUAL PERFORMANCE/MERIT REVIEWS
• ANNUAL PERFORMANCE BONUSES
• EQUITY
• SPECIAL RECOGNITION
• FULLY REMOTE WORK ENVIRONMENT
• REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off
• HOLIDAYS – 14 holidays in 2025
• 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 1 x base salary + Voluntary Plans
• ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More

Additional Information

• CG Oncology does not accept unsolicited resumes from search firms or agencies without a contract.
• The company is an equal opportunity employer, promoting diversity and inclusion.