Teams at Zai Lab

Leads global CMC regulatory strategy and execution for small-molecule and biologic programs across development phases. Oversees IND, CTA, NDA, BLA, and MAA dossier preparation, submissions, agency interactions, risk assessments, and post-approval GMP support. Provides regulatory guidance to cross-functional teams, ensures compliance with international requirements, develops processes, and manages CMC regulatory professionals. Requires extensive scientific and regulatory expertise, bilingual English and Chinese communication, and experience with global health authorities.

Leads Zai Lab’s Clinical Pharmacology function and serves on the Development Leadership Team. Develops clinical pharmacology and model-informed drug development strategies across small molecules, biologics, and other therapeutics. Oversees PK/PD, exposure-response, modeling, simulation, dose projection, bioanalytical activities, CROs, and regulatory submissions and interactions. Partners cross-functionally on global development, portfolio decisions, due diligence, and business development while building a high-performing clinical pharmacology organization.

Conduct independent, risk‑based QC assessments (on‑site and remote) to verify investigational sites follow protocol, GCP, and company procedures; produce QC reports, track findings, support RCA/CAPA, inspection readiness, training, and process improvements.