Tycoon Chen Email & Phone Number

With 16+ years in the pharmaceutical industry, I specialize in global serialization, vaccine project management, regulatory affairs, and quality systems implementation. My background in IT project management ensures seamless integration of technology in pharma operations.Pharmaceutical Industry Experience (2007 - Present):1. Global Serialization & Track & Trace Led serialization projects to ensure compliance with global regulations.2. WHO Framework & Vaccine Coordination Company contact for WHO PIP, IFPMA, NYMC,MHRA,VIDRL or TGA.3. CMO Serialization Project for customers(i.e.Sanofi,Techdow,SamChunDang) Managed serialization projects, awarded by Sanofi for excellence.4. WHO Flu Vaccine Analysis Annual analysis and forecasting for WHO Candidate Vaccine Virus (CVV).5. Vaccine Bulk-Antigen & Clinical Trials Engaged in vaccine manufacturing and CMO projects in Switzerland, Japan, USA, and Phase 3 trials in Belgium.6. EU-EMA & CMDh Regulatory Affairs Managed MAH applications, transfers, and post-authorization procedures.7. Pharma & Medical Devices Regulatory Expertise Knowledge of PICS, ICH, FDA, IMDRF, ISO standards.8. Influenza Plant & Lab Construction Managed plant construction, overseeing service providers.9. Advanced Vaccine Development

Listed skills include International Affairs, Computer System Validation, Information System Audit, Pharmaceutical Quality Assurance And Validation, and 9 others.

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  Oklahoma City University

  Master Of Computer Science