Regulatory Affairs Lead @ (October 2019 - Present)
Regulatory Affair Project Manager @ (December 2014 - October 2019)
Regulatory Associate @ (January 2013 - December 2014)
Technological and Scientific Affairs (T and SA) Section Manager @ Teva Pharmaceutical Industries Ltd. (January 2009 - January 2013)
Technological and Scientific Affairs (T and SA) Researcher @ Teva Pharmaceutical Industries Ltd. (January 2006 - January 2009)
Hagit Levi Education
Ben-Gurion University of the Negev
Bachelor of Science (BSc) (Biotechnology Engineering)
2002-2006
Hagit Levi Skills
Validation
R&D
FDA
Biotechnology
Pharmaceutical Industry
GMP
Sop
Lifesciences
Regulatory Affairs
CAPA
Clinical Development
Regulatory Submissions
HPLC
Clinical Trials
Medical Devices
Technology Transfer
V&V
Biopharmaceuticals
Regulatory Requirements
Regulatory Documentation
Regulatory Filings
Regulatory Guidelines
Drug Discovery
Protocol
Quality System
Formulation
Dissolution
Drug Development
Change Control
21 CFR Part 11
GxP
GLP
CTMS
Oncology
GCP
Vaccines
Chromatography
Sterilization
Analytical Chemistry
Generic Programming
CRO
Immunology
Biochemistry
LIMS
Cleaning Validation
Computer System Validation
Quality Assurance
Pharmaceutics
ISO 13485
Aseptic Processing
Regulatory
Microsoft Word
Project Planning
Management
Hagit Levi Summary
Hagit Levi, based in Israel, is currently a Head of Regulatory Affairs at PolyPid Ltd.. Hagit Levi brings experience from previous roles at PolyPid Ltd. and Neopharm Group. Hagit Levi holds a 2002 - 2006 Bachelor of Science (BSc) in Biotechnology Engineering @ Ben-Gurion University of the Negev. With a robust skill set that includes Validation, R&D, FDA, Biotechnology, Pharmaceutical Industry and more. Hagit Levi has 2 emails on RocketReach.
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