Cindy Fisher
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Director of Regulatory Affairs at Helixmith Co., Ltd.
About
I am a Regulatory Affairs professional with 15+ years of experience acting as the regulatory lead on product development teams for biologics and pharmaceuticals for rare and infectious diseases. I have been instrumental in numerous successful global regulatory filings including multiple INDs and CTAs; IMPDs; and orphan drug, Fast Track, and Qualified Infectious Disease Product designations. In preparation for BLA filing, I led company efforts in CTD development and authored major sections. I am dedicated to bringing medical products to people that will help them lead longer, healthier lives.
Experience
Director of Regulatory Affairs
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Company NameHelixmith Co., Ltd.
Dates EmployedMay 2019 – PresentEmployment Duration2 mos
LocationGreater San Diego Area
Director of Regulatory Affairs
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Company NameVical Incorporated
Dates Employed2003 – 2019Employment Duration16 yrs
LocationGreater San Diego Area
* Act as regulatory lead on plasmid DNA vaccines, novel antifungal drug including regulatory strategy development
* Spearhead preparation of project submissions such as INDs; applications for orphan drug, QIDP, Fast Track designations; briefing documents
* Liaise with regulatory agencies, including coordinating and chairing both telephonic and in-person meetings
* Lead CMC section development of BLAs
* Develop and maintain Drug Master Files
* Manage partnered vaccine development as CMC coordinator See less
Education
University of California, Irvine
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Degree NamePhD
Field Of StudyPhysical Organic Chemistry
Activities and Societies: Associated Graduate Students representative, UCI Alumni Association
University of California, Los Angeles
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Degree NameBachelor of Science - BS
Field Of StudyChemistry
Activities and Societies: UCLA Alumni Association