Yuwei Wang Email & Phone Number | I am a pharmaceutical professional with a PhD in Pharmaceutics and over nine years of experience in formulation and process development, cGMP manufacturing, and regulatory affairs. My regulatory affairs knowledge is supported by a strong foundation in hands-on industry product development. I have worked with both small molecules and biologics, authoring eCTD Module 3 sections and project reports for NDA and BLA submissions. My competencies include change control management, compliance review, preparing submission-ready dossiers, formulation innovation, process development, and tech transfer. I have successfully managed Health Authority interactions and led cross-functional teams, contributing to the FDA approval of ELEVIDYS and the manufacture of liposomal siRNA clinical supplies for a Phase II study.

Yuwei Wang

I am a pharmaceutical professional with a PhD in Pharmaceutics and over nine years of experience in...
Irvine, California, United States

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Senior Manager, Regulatory Affairs CMC - Gene Therapy

2022-04-01 00:00:00 - 2024-04-01 00:00:00

Assistant Professor of Pharmaceutics & Regulatory Affairs

2018-08-01 00:00:00 - 2022-04-01 00:00:00

Senior Scientist - Kybella® 2nd Generation Formulation & Process Development

2016-08-01 00:00:00 - 2018-06-01 00:00:00

Project Lead – Clinical Supply Manufacturing

2015-04-01 00:00:00 - 2016-06-01 00:00:00

Post Doc Scientist – Cell Assy Development for Preclinical Study

2011-09-01 00:00:00 - 2013-03-01 00:00:00

Research Assistant - Department of Pharmaceutics & Pharmaceutical Chemistry

2006-08-01 00:00:00 - 2011-10-01 00:00:00

Research Assistant & Protein Lab Manager - Department of Medicinal Chemistry

2003-09-01 00:00:00 - 2006-05-01 00:00:00

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Yuwei Wang is a I am a pharmaceutical professional with a PhD in Pharmaceutics and over nine years of experience in formulation and process development, cGMP manufacturing, and regulatory affairs. My regulatory affairs knowledge is supported by a strong foundation in hands-on industry product development. I have worked with both small molecules and biologics, authoring eCTD Module 3 sections and project reports for NDA and BLA submissions. My competencies include change control management, compliance review, preparing submission-ready dossiers, formulation innovation, process development, and tech transfer. I have successfully managed Health Authority interactions and led cross-functional teams, contributing to the FDA approval of ELEVIDYS and the manufacture of liposomal siRNA clinical supplies for a Phase II study.

Yuwei Wang has prior
experience in the following industries:
Sarepta Therapeutics | California Health Sciences University | Allergan | Nitto Americas | Nitto Denko | University Of Utah | Peking University

Yuwei Wang has the following professional experience:
Sarepta Therapeutics | California Health Sciences University | Allergan | Nitto Americas | Nitto Denko | University Of Utah | Peking University