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Melanie Leibowitz Location
Ho-Ho-Kus, NJ, US
Melanie Leibowitz Work
2024 -now Senior Vice President Quality and Regulatory Affairs @
2022 -2024 Vice President Quality and Regulatory Affairs @
2020 -2022 Vice President Quality and Regularory Affairs @
2020 -2022 Chief Compliance Officer @
2019 -2020 Vice President Quality and Regulatory Affairs @
2018 -2019 Vice President Quality Operations @
2013 -2018 Quality and Regulatory @
2012 -2013 Vice President of Regulatory Compliance @
2011 -2012 Vice President Regulatory Affairs @
2009 -2011 Senior Director of Regulatory Affairs @
2007 -2009 Director of Worldwide Regulatory Affairs @
1998 -2013 Quality and Regulatory @
Melanie Leibowitz Education
Rutgers, The State University of New Jersey-New Brunswick
Bachelor of Arts (B.A.) (Biology, General)
1993-1997
Melanie Leibowitz Skills
Pharmaceutical Industry
Quality System
Medical Devices
Validation
GLP
Cross-functional Team Leadership
ISO 13485
Technology Transfer
Consumer Products
21 CFR Part 11
Quality Assurance
Quality Auditing
Regulatory Submissions
Regulatory Requirements
Strategic Planning
FDA
FDA GMP
Compliance
Risk Management
Risk Assessment
21 CFR 210/211
21 CFR 820
Adverse Event Reporting
GxP
SOP authoring
Health Canada
ISO 9001
Management
Department Budgeting
Cosmetics
NDA
Quality Management
Quality Operations
Regulatory Agencies
Regulatory Affairs
Regulatory Operations
Regulatory Documentation
Regulatory Guidelines
Regulatory Interactions
Regulated Industry
Regulatory Projects
Compliance Procedures
Compliance Investigations
Safety Compliance
SOP development
Department Creation
Strategist
CARB
EPA
FIFRA
Cross Functional Team Leadership
Melanie Leibowitz Summary
Melanie Leibowitz, based in Ho-Ho-Kus, NJ, US, is currently a Senior Vice President Quality and Regulatory Affairs at iCAD. Melanie Leibowitz brings experience from previous roles at Proscia, Kheiron Medical and Happify Health. Melanie Leibowitz holds a 1993 - 1997 Bachelor of Arts (B.A.) in Biology, General @ Rutgers, The State University of New Jersey-New Brunswick. With a robust skill set that includes Pharmaceutical Industry, Quality System, Medical Devices, Validation, GLP and more. Melanie Leibowitz has 2 emails and 1 mobile phone numbers on RocketReach.
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