Deep Enrich
Winnie Chen
175 followers
Hsinchu City, Taiwan, Taiwan
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About me
Former Regulatory Affairs Manager（Savior Lifetec Corp.）
Education
高雄醫學大學
2004 - 2011Doctor of Philosophy (Ph.D.) Medicinal and Applied ChemistrySynthesis and development of anti-cancer compound
Experience
Savior Lifetec Corp.
Mar 2011 - Mar 2018Supervise the following activities:- DMF/Product dossier development- Submission of DMF/Dossiers- Worldwide deficiency response - Filing of amendments- Annual reports- Maintenance of site GMP certificates- Coordinating for GMP inspections- GMP inspection presentations- Working with clients for worldwide Market Authorization submissions- Liaising with clients for regulatory issues Supervise the following activities:- DMF/Product dossier development- Submission of DMF/Dossiers- Worldwide deficiency response - Filing of amendments- Annual reports- Maintenance of site GMP certificates- Coordinating for GMP inspections- GMP inspection presentations- Working with clients for worldwide Market Authorization submissions- Liaising with clients for regulatory issues - DMF development- Submission of DMF- Deficiency response- GMP inspection presentations- Working with clients for worldwide Market Authorization submissions- Liaising with clients for regulatory issues
Regulatory Affairs Manager
Apr 2016 - Mar 2018Regulatory Affairs Associate Manager
Oct 2013 - Apr 2016Senior Regulatory Affairs Specialist
Oct 2011 - Sept 2013Research Specialist
Mar 2011 - Oct 2011
GIS (Generic International Summit) Asia 2019
Apr 2019 - Apr 2019SpeakerSpeech topic: Difference in US & EU Requirement of Sterile API Filing
Licenses & Certifications
度智慧財產人員能力認證
TIPA 智慧財產培訓院
Languages
- 中文中文
- enEnglish
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