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陳毓茹
Senior regulatory affair specilalist
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陳毓茹

Senior regulatory affair specilalist
With a Bachelor's degree in Pharmacy and a Master's degree in Pharmacology, I have developed a strong foundation in medical concepts essential to clinical practices. I have worked as a pharmacist in a hospital setting, where I have been responsible for providing pharmaceutical services such as medication consultations, drug dispensing, and patient education for two yeas. I have gained extensive experience in clinical trials during my two-year as a medical writer for a CRO. In this role, I played a key role in designing BA/BE studies and successfully completed numerous BE studies. I have also been involved in a phase I study and a phase II study, providing me with a fundamental understanding of clinical study design. Subsequently, I served as a primary clinical reviewer at Taiwan's Ministry of Health and Welfare's Center of Drug Evaluation for two years, where I reviewed new drug applications and gained insights into the regulatory perspective of evaluating clinical trial results, including efficacy and safety assessment, as well as risk and benefit evaluation. Throughout my career, I have consistently demonstrated a strong passion for clinical medical research and a dedication to expanding my understanding of this field. Furthermore, my comprehensive involvement in designing phase I and phase II studies, has provided me with practical insights into clinical trial design and its associated challenges. This hands-on experience, complemented by my role as a primary clinical reviewer, has given me a deep appreciation for the regulatory perspective and the critical evaluation of clinical trial results. I am eager to contribute my knowledge and skills in clinical field.
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Exfluency
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National Cheng Kung University
Hsinchu, Hsinchu City, Taiwan

Professional Background

  • Current status
    Employed
    Ready to interview
  • Profession
    Pharmacist
    Biotechnology Researcher
    Translator
  • Fields
    Medical Devices
  • Work experience
    4-6 years (4-6 years relevant)
  • Management
  • Skills
    powerpoint
    專案管理
    outlook
    excel
    Word
  • Languages
    English
    Professional
  • Highest level of education
    Master

Job search preferences

  • Desired job type
    Full-time
    Interested in working remotely
  • Desired positions
    法規人員、臨床試驗專員
  • Desired work locations
  • Freelance
    Part-time freelancer

Work Experience

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Medical translator

Exfluency
Freelance
Jun 2022 - Present
·Precisely and accurately interpreted critical medical advice and information given by the provider into equivalent terminology in the patient's native language. ·Translate/ localize medical from Traditional Chinese to English ·Translated medical text from English on behalf of customers as specifically requested.
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Senior Regulatory Affairs Specialist

Apr 2022 - Present
· Wrote a customized regulatory gap analysis report of Oncology drug for NDA submission · Wrote a BSE report (Oncology drug) for BSE submissions · Completed a NDA submission and get a license in HK · Coordinated two NDA regulatory strategy consultation in Taiwan · Complete a PMF submission and get PMF approval.

Clinical Evaluation Reviewer

Jul 2020 - Apr 2022
1 yr 10 mos
Taichung City, Taiwan
· Evaluated new drug applications (monoclonal antibody for oncology and OTC for constipation). · Evaluated post-market surveillance reports for safety concerns (oncology). · Evaluated risk management plans/reports. · Evaluated SUSAR and analyzed investigation drug safety profile and reported to TFDA. · Translated regulatory related guidelines.

Medical Scientist/Writer

May 2018 - Mar 2020
1 yr 11 mos
Taichung City, Taiwan
·Wrote 14 clinical study protocols for bioequivalence studies under various countries regulatory requirements ·Wrote one Phase I clinical protocol, one patient support study. ·Wrote clinical study reports for Phase II oncology trials and Pharmacokinetics study and 12 bioequivalence studies. ·Prepared essential documents for IRB and authorized agency submission including study synopses, informed consent forms, and response to reviewers. ·Performed other medical science related tasks including medical coding, safety reporting (to IRBs and local ADR center), case report form reviewing and clinical data reviewing. ·Performed medical related training for clinical operation team

Pharmacist

Sep 2013 - Dec 2015
2 yrs 4 mos
Hsinchu, Hsinchu City, Taiwan
·Dispensed medications by compounding, packaging, and labeling pharmaceuticals. ·Pharmacy service including preparation of medications, giving pharmacological information to multidisciplinary health care team, and monitoring patient drug therapies. ·Prepared medications by reviewing and interpreting physician orders and detecting therapeutic incompatibilities. ·Provided pharmacological information by answering questions and requests of health care professionals and counseling patients on drug therapies ·Participated in use of antibiotic guide line establishment for internal SOP

Education

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Master’s Degree
Pharmacology
2015 - 2017
Description
Major: pharmacology · Course: advanced molecular biology , new drug development, introduction to pharmacokinetic data analysis, translational medicine, translational medicine and clinical trial, dementia and aging research, introduction to clinical trial research, TDM Master's thesis: Aging-induced Akt activation involves in aging-related pathologies and Aβ-induced toxicity
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Bachelor’s Degree
Pharmacy
2008 - 2013
Description
· Major: pharmacy · Courses: pharmaceutical analysis, dispensing pharmacy, drug therapeutics, biopharmaceutics, clinical pharmacy, pharmaceutical chemistry

Licenses & Certifications

SDL Trados Studio 2021 for Translators_Level 1

RWS Trados Business Manager
Issued Nov 2021
No Expiration Date
Coursera
Credential ID: Z27Y5RKUD7GG
Issued Jun 2020
No Expiration Date