Mei-Fang Chen
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.
Industries Experience
See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.
Experienced in Pharmaceutical (14 years).
Business Areas Experience
The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.
Experienced in Quality Assurance (12.5 years), Product Development (2.5 years), Research and Development (2.5 years), and Operations (2.5 years).
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
Skills
Spreadsheets/excel
Data Cleaning
Exploratory Da
Sql (Postgresql)
Statistical Da
Machine Learning
Data Visualization
Tableau
Segmentation Analysis
Time Series Analysis
Problem-solving
Collaboration & Teamwork
Communication And Presentation
Intellectual Curiosity
Project Management
Adaptiability
Languages
Education
Furtwangen University, Germany
Master of Health, Medical and Life Sciences · 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
Introduction To Tableau
Profile
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