Drug Registration: Managed regulatory affairs for more than 5 generic and innovative products of international market registration. Drafted, reviewed, and compiled CMC dossiers, contributed process improvements and optimized team efficiency in regulatory submission activities. Supported 10+ successful API registrations for drug product clients, with 5+ successful market entries (including US/EU/Japan/Korea) and secured FDA approval for 1 ANDA. Communication & Coordination: Maintained strong relationships with regulatory agencies, external agents/clients, and CDMOs to facilitate registration processes. Collaborated cross-functionally with internal R&D, manufacturing, quality, and business teams to mitigate compliance risks. Advised regulatory strategies for specified products and provided regulatory guidance in therapeutic areas. Provided scientific and technical support to 60+ clients across US/EU/Asia, etc., facilitating dossier submissions, tracking regulatory requests, and deficiency responses to accelerate commercialization. Regulatory Intelligence & Scientific Research: Monitored and analyzed regulatory updates, guidelines and pharmacopoeia to assess the impact on product registration and compliance. Conducted literature reviews and CMC data analysis to support regulatory strategy formulation and evidence-based decision-making. Training: Assisted in organizing and delivering 9+ regulatory trainings, including 3 cross-departmental programs, with 30+ participants.

Focus: Efficacy and Quality Evaluation of Traditional Chinese Medicine (TCM) / Metabolomics Publication: Research Process on Mechanisms of Natural Polysaccharides in Improve UC / Comparison of Semen Aesculi species from different geographical origins and horse chestnut based on metabolomics and chemometrics analysis

GPA Certification: 3.76/4.0 (Ranking 1/93) Courses: Chemistry, Pharmaceutics, Pharmacology, Engineering Principle and Equipment, Drug Administration Law, etc.