Yu-Fen Wang Email & Phone Number
Associate Vice President, Global Regulatory Affairs CMC @ Organon
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Yu-Fen Wang Location
- United States
Yu-Fen Wang Work
- Associate Vice President, Global Regulatory Affairs CMC @ (June 2021 - Present)
- AVP, Regulatory Affairs CMC @ (December 2020 - June 2021)
- Vice President, Head of Global Regulatory Affairs CMC @ (April 2018 - December 2020)
- Head of Regulatory Affairs United States @ (January 2017 - April 2018)
- Senior Director, Regulatory Affairs CMC (Vaccine and Biologics) @ (June 2016 - January 2017)
- Director, Global CMC Asia Regional Lead (Innovative products) @ (October 2013 - May 2016)
- Director, Global Regulatory Affairs CMC (Vaccines) @ (April 2011 - September 2013)
Yu-Fen Wang Education
- Ion College, Hagan Business School
Master Of Business Administration (Finance)
2001-2006 - Baylor College of Medicine
(Molecular Biology, Biology)
1994-1996 - University Of California - Riverside
Doctor Of Philosophy
1989-1993
Yu-Fen Wang Skills
- 21 CFR Part 11
- Antibody conjugates
- Asia Regulatory Requirements
- Assay Development
- Biologics
- Biologics and vaccine
- Biologics registration in China
- CMC
- CMC Regulatory Affairs
- Change Control
- China FDA/Center of Drug Evaluation interaction
- Clinical Development
- Cross-functional Team Leadership
- Development and Commercial products
- FDA
- FDA interactions
- GMP
- Global Regulatory Compliance
- Global regulatory requirements
- Health authority interaction US/China
- Inspection
- Management
- Manufacturing site transfer
- Monoclonal Antibodies
- New Business Development
- Oncology
- Pharmaceutical Industry
- Product registration through launch
- Registration in Japan
- Regulatory Affairs
- Regulatory Submissions
- Regulatory strategy in China
- Research and Development (R&D)
- Standard Operating Procedure (SOP)
- Team Leadership
- Team Management
- Technical Transfer and comparability
- Technology Transfer
- U.S. Food and Drug Administration (FDA)
- U.S. Title 21 CFR Part 11 Regulation
- Vaccines
- Variation and supplement
- acceleration pathway
- cell and gene therapy
- eCTD
- global regulatory landscape
- Clinical Trials
- Verification and Validation V&V
- Chemistry
- Roadshow and Conferences
- Retail and Office Fit
- Exhibition Stand Manufacture
- Biotechnology
- Point of Sale Manufacture
- Cmc Biologics
- Board of Health Interaction
- Manufacturing and Control
- Cmc Strategy for Localization
- Graphic Design and Production
- Global Submission Stratrgies
- u.s. Food and Drug Administration Fda
- Exhibition Stand Design
- Formulation
- Standard Operating Procedure Sop
- Worldwide Exhibition Stand Contractor
- Cytokines
- Sop
- Resource Allocation
- Standard Operating Procedure
- u.s. Food and Drug Administration
Yu-Fen Wang Summary
- Yu-Fen Wang, based in United States, is currently a Associate Vice President, Global Regulatory Affairs CMC at Organon. Yu-Fen Wang brings experience from previous roles at Merck, Tessa Therapeutics Ltd., Kedrion Biopharma Inc. and Pfizer. Yu-Fen Wang holds a 2001 - 2006 Master Of Business Administration in Finance @ Ion College, Hagan Business School. With a robust skill set that includes 21 CFR Part 11, Antibody conjugates, Asia Regulatory Requirements, Assay Development, Biologics and more. Yu-Fen Wang has 1 emails and 1 mobile phone numbers on RocketReach.
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