Skills:
Over 10 years of Regulatory experience in the pharmaceutical industry Knowledgeable of the Code of Federal Regulations for Food and Drugs (CFR Title 21) Proficiency in the following software, applications, and doc-base systems: Windows 8, 7, Office, Word, Excel, Powerpoint, Sharepoint, Project, Adobe Acrobat 9, Documentum, eCTD Xpress, ISI Publisher, ISIToolbox, DocComposer, CRF Track, Global Submit Validate, Checksums Fix MD5, XML, ARISg, Rosetta Phoenix, Pyramid, FDA (ESG) Electronic Submissions Gateway, Webtrader and MyWebmethods (AS1, AS2, AS3 Protocols).