Zai Lab

Compliance

• Support development and execution of clinical regulatory strategies for assigned programs
• Contribute regulatory analyses, options, and recommendations
• Plan, prepare, and manage IND applications and other pre- or post-IND submissions
• Manage regulatory timelines, deliverables, and commitments with cross-functional teams
• Prepare health authority meeting materials, responses to information requests, and supporting documentation
• Participate in health authority interactions
• Provide clinical regulatory guidance to cross-functional teams
• Provide regulatory input into protocols, Investigator’s Brochures, and study reports
• Execute regulatory activities in compliance with global and regional regulations, industry guidelines, and internal policies
• Maintain inspection-ready documentation and practices
• Identify regulatory risks, issues, and gaps and develop mitigation approaches
• Lead clinical regulatory execution on cross-functional teams
• Coordinate inputs from Clinical, Nonclinical, Biometrics, Medical Writing, CMC, and other functions
• Partner with CMC Regulatory Affairs and technical subject matter experts
• Monitor regulatory developments and assess potential impacts
• Contribute to regulatory processes, templates, and tools

Associate Director, Regulatory Affairs