Teams at Zai Lab Limited

Leads global CMC regulatory strategy and execution for small-molecule and biologic programs across development phases. Oversees regulatory dossier preparation, submissions, agency interactions, risk assessments, post-approval GMP activities, and compliance with international guidelines. Provides strategic guidance to cross-functional teams, manages regulatory CMC professionals, develops internal processes, and supports interactions with NMPA, FDA, EMA, and other health authorities.

Leads Zai Lab’s Clinical Pharmacology function and provides strategy across global drug development programs involving small molecules, biologics, and innovative therapeutics. Oversees PK/PD, exposure-response, modeling and simulation, dose projection, bioanalytical activities, regulatory submissions, CROs, external collaborations, and health-authority interactions. Partners with cross-functional development teams, supports business development and due diligence, and builds a high-performing clinical pharmacology organization.

Lead independent, risk‑based quality control (QC) assessments of investigational sites to verify protocol adherence, GCP compliance, and data integrity. Develop QC plans/tools, conduct on‑site and remote reviews, document findings, support RCA/CAPA, track remediation, and contribute to inspection readiness, training, and process improvement in partnership with Clinical Operations teams.