Mei-fang C.
Medical Consultant
Experience
Medical Consultant
Atheneum
Provided expert consultation by analyzing clinical and market data for 20+ cases, driving data-driven pipeline decisions that optimized R&D prioritization and accelerated project timelines.
Advised on reimbursement pathways and pricing for critical medicines, aligning clinical data with payer expectations.
CMC Section Chief
Center for Drug Evaluation (CDE)
Directed data-informed prioritization strategies during COVID-19, helping prevent supply shortages in 50+ critical medicines.
Developed standardized templates and workflows, increasing regulatory review efficiency by 30%.
Senior Reviewer
Center for Drug Evaluation (CDE)/Taiwan Food and Drug Association
- Analyzed 1,300+ regulatory dossiers using international guidelines (ICH, EMA, FDA) to assess manufacturing data and quality metrics, supporting drug approvals and advancing Taiwan’s global-aligned review capabilities.
Director of New Drug Development
Oneness Ltd
- Directed cross-functional teams and vendors (CROs/CMOs) to guarantee on time Phase III and NDA submissions.
Senior Reviewer
Center for Drug Evaluation (CDE)/Taiwan Food and Drug Association
- Analyzed 1,300+ regulatory dossiers using international guidelines (ICH, EMA, FDA) to assess manufacturing data and quality metrics, supporting drug approvals and advancing Taiwan’s global-aligned review capabilities.
Summary
PhD-trained professional with deep expertise in data analytics, drug quality control and regulatory affairs. Skilled in team leadership, cross-functional management and process optimization, with a track record of improving regulatory efficiency, guiding new drug development, and driving data-informed decisions that accelerate R&D and market access
Languages
Education
Furtwangen University
Master of Health, Medical and Life Sciences · Villingen-Schwenningen, Germany
National Taiwan University
PhD of Chemistry · Chemistry · Taipei, Taiwan, Province of China
National Taiwan University
Master of Chemistry · Chemistry · Taipei, Taiwan, Province of China
Certifications & licenses
Intermediate To Google Sheets
Introduction To Deep Leaning With Keras
Data Analytics Training Program
Masterschool
Introduction To Tableau
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