Guangyuan (Claire) Li is a Senior Regulatory Project Manager at ELIQUENT Life Science. She manages biologics and small molecule projects at various stages of clinical development, from early to late phases. Her role includes managing project timelines, serving as the primary point of contact for coordinating and communicating with internal subject matter experts and external stakeholders as well as health authorities, and providing regulatory guidance to support eCTD submissions.

In Guangyuan’s current position as a senior regulatory project manager, she has managed and contributed to more than 10 Investigational New Drug (IND) Applications and a variety of other regulatory submissions. These include Breakthrough Designation Request (BTDR), Fast Track Designation, Orphan Drug Designation (ODD) Request, Initial and Agreed Pediatric Study Plans (iPSP), INTERACT meeting request/meeting package, pre-IND/end of phase (EOP)/Type D meeting request/meeting package.

Before joining ELIQUENT, Guangyuan was a Project Manager at Wuxi Biologics and was an ORISE postdoctoral fellow at the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), FDA.