About me
Multidisciplinary pharmaceutical expert with a solid foundation in clinical pharmacy and extensive experience in regulatory strategy, clinical review, and global drug development. Specialized in benefit–risk assessment of NDA/BLA and IND submissions, post-approval efficacy/safety confirmation, and cross-functional collaboration with experts in statistics, PK/PD, Pharm/Tox, Biologics, and CMC. Recognized for driving regulatory decisions through evidence-based clinical and safety evaluations across oncology, biosimilars, and other high-impact therapeutic areas. Contributed to the development of the ICH E2D (R1) guideline alongside international regulators and pharmacovigilance leaders.
