Manager, Regulatory Affairs (CMC & Clinical)

About the role

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.

Location: Remote

Essential Functions

• 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.

Qualifications

• 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 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
• EQUITY
• 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.

• FULLY REMOTE WORK ENVIRONMENT
• REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off
• HOLIDAYS –In 2025 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 1 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.