With over 15 years of experience in regulatory affairs within internationally renowned pharmaceutical and biotech companies, successfully navigated the entire spectrum of drug development from pre-IND applications to post-NDA approvals. This includes extensive work in oncology and central nervous system therapeutic areas (CNS TAs), as well as chemical and biological products.
Capable of promptly grasping and flexibly responding to the ever-changing registration regulations as well as the rapidly evolving competitive landscape, formulating optimal registration strategies for project advancement through insightful regulatory interpretations, in-depth evaluations, and flawless execution.