Mei-fang C.

Medical Consultant

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Hanover, Germany

Experience

Aug 2024 - Present
1 year 5 months

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.
Jan 2019 - Aug 2021
2 years 8 months
Taipei, Taiwan, Province of China

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%.
Jan 2016 - Dec 2018
3 years
Taipei, Taiwan, Province of China

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.
Mar 2015 - Dec 2015
10 months
Taipei, Taiwan, Province of China

Director of New Drug Development

Oneness Ltd

  • Directed cross-functional teams and vendors (CROs/CMOs) to guarantee on time Phase III and NDA submissions.
Jan 2009 - Dec 2015
7 years
Taipei, Taiwan, Province of China

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

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

Chinese
Native
German
Intermediate
English
Intermediate

Education

Sep 2021 - Jul 2023

Furtwangen University, Germany

Master of Health, Medical and Life Sciences · Health, Medical and Life Sciences · Villingen-Schwenningen, Germany

Sep 2003 - Jul 2007

National Taiwan University

PhD of Chemistry · Chemistry · Taipei, Taiwan, Province of China

Sep 1998 - Jun 2000

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

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