Krupali Maniar
Senior Associate, Global Regulatory Systems & Process Managment at Eisai Us
Based in New York, United States
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Seniority
Manager
Department
General Business & Management
Location
New York
Industry
Pharmaceutical Manufacturing
Company size
2.8K
Contact information
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k•••••••@eisai.com
Phone
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Background
About Krupali Maniar
Proactive Regulatory Affairs Professional with 6+ years of work experience and 11+ years of pharmaceutical/management education. with proven knowledge of regulatory compliance. • Experience in preparing, compiling, reviewing and processing regulatory submissions (IND, NDA, BLA, MAA, DMF, SNDS, CTA, NDS, ANDS,PMA, 510(k)) in accordance with regulatory requirements of respective health authorities (FDA, EMA, Health Canada) • Specialist in regulatory Tools like LORENZ docuBridge, eCTDXPress, Liquent IP, ISI Toolbox, CARA (EDMS), Veeva Vault, Insight Validator, Global Submit Validator, IQVIA Validator, Adobe Acrobat Pro, SharePoint & Citrix • Great with regulatory technology and troubleshooting along with hands on experience in creating work instructions, job aids, templates and style guides to ensure smooth workflow
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