Job Number:
HC-03967
Date Posted:
March 27, 2026
Position Title:
Manager, Regulatory Affairs (CMC & Clinical)
Party:
N/A
Office Code:
Office/Company:
CG Oncology
Reports To:
Location:
Remote
Contact:
Salary:
125,000 – 145,000 USD per year
Primary Role
Secondary Role:
Job Type:
Full Time
Description:
Support the development and execution of regulatory strategies for assigned programs, with a balanced focus on CMC and Clinical Regulatory Affairs.Regulatory Strategy Support, Regulatory Submissions & Documentation, CMC & Clinical Regulatory Support, Cross-Functional Collaboration, Health Authority Interaction Support, Compliance & QualityBachelor’s degree in a scientific or related discipline, Five (5) years of regulatory affairs experience in pharmaceutical or biotechnology development
Responsibilities:
• 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).
• Draft, review, and coordinate regulatory documents for submissions including INDs, IND amendments, annual reports, briefing documents, IBs, and responses to health authority requests.
• Provide regulatory input to CMC teams related to manufacturing changes, comparability, specifications, and lifecycle management.
• Act as a regulatory representative on project teams, working closely with Clinical Development, CMC, Quality, Nonclinical, and Regulatory Operations.
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
Instructions:
Email [email address]
Other:
CG Oncology does not accept unsolicited information and/or resumes from search firms or agencies for our job postings.
