Irisha Johnson
Regulatory Operations Consultant Global Submissions Publisher at Triangle Regulatory Publishing
Based in Raleigh, United States
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Seniority
Staff
Department
Other
Location
Raleigh
Industry
Pharmaceutical Manufacturing
Company size
8
Contact information
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i•••••••@triangleregulatorypublishing.com
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Background
About Irisha Johnson
Innovative and resourceful professional with a demonstrated record of achievement in diverse areas of regulatory operations. Adept in the conversion from a paper environment to an electronic environment including eCTD / CTD / Hybrid submissions. High level of proficiency using industry standard publishing systems including but not limited to Lorenz DocuBridge, Liquent Insight Publisher, eCTD Express, and Quantum. Extensive experience utilizing industry standard document management systems. Highly experienced in managing the entire electronic submission and archive process from inception through completion. Specializing in paper to electronic conversion and lifecycle management of Chemistry Manufacturing and Control (CMC) documents. Accomplished professional with the ability to collaborate effectively with all members of the organization to achieve objectives. Expertly navigated a dynamic and constantly changing professional environment. Specialties: Regulatory Operations | Electronic Publishing | eCTD LifeCycle Management | PDF Navigation | Document Formatting | Electronic Submission Gateway
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