Lead development and oversight of regulatory submission documents (protocols, CSRs, IBs, NDAs/MAAs/INDs), manage end-to-end writing for high-priority programs, coordinate cross-functional input, translate complex clinical/scientific data into clear regulatory narratives, and drive process improvements for regulatory writing and submissions to global health authorities.

Lead global pharmacovigilance and risk management activities: chair SRMT, detect and assess safety signals, author safety documents (RMP, DSUR, PBRER), perform medical review of ICSRs and aggregate reports, support regulatory interactions, inspection readiness, SOP maintenance, and safety-related agreements.