Michael Vandi Email & Phone Number
Principal Consultant, Regulatory Labeling @ Opus Regulatory Inc.
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Michael Vandi Location
- Boston, MA, US
Michael Vandi Work
- 2026 -now Principal Consultant, Regulatory Labeling @
- 2024 -2026 Director, Global Labeling Strategy, Respiratory and Immunology @
- 2022 -2024 Associate Director, Global Labeling Strategy, Oncology @
- 2020 -2022 Senior Manager, Global Labeling and US Lead, Rare Disease @
- 2019 -2020 Team Lead, Global Regulatory Affairs @
- 2019 -2019 Manager, Global Regulatory Affairs @
- 2018 -2019 Manager, Global Regulatory Affairs @
- 2017 -2018 Senior Quality Assurance Specialist @
- 2016 -2017 Quality Engineer Consultant @
- 2014 -2015 Compliance Specialist II, CMC, Gene and Cell Therapy @
- 2012 -2014 Quality Systems Engineer @
- 2012 -2012 Quality Assurance Specialist @
- 2011 -2012 Quality Assurance Associate @ Toxikon Corporation
Michael Vandi Education
- Northeastern University
Master of Science (M.S.) (Regulatory Affairs)
- University of Massachusetts Lowell
Bachelor of Science (B.S.) (Biology)
Michael Vandi Skills
- Biotechnology
- Quality System
- GMP
- Quality Assurance
- Validation
- Regulatory Submissions
- GLP
- FDA
- SOP
- Change Control
- Pharmaceutical Industry
- 21 CFR Part 11
- CAPA
- Life Sciences
- Regulatory Affairs
- Biopharmaceuticals
- Clinical Trials
- GCP
- Medical Devices
- SOPs
- Cell Culture
- Lifesciences
- Technology Transfer
- Good Laboratory Practice (GLP)
- U.S. Title 21 CFR Part 11 Regulation
- Standard Operating Procedure (SOP)
- Good Clinical Practice (GCP)
- Regulatory Documentation
- New Drug Application (NDA)
- IND
- BLA
- Common Technical Document (CTD)
- CTA
- Electronic Common Technical Document (eCTD)
- Regulatory Compliance
- Regulatory Requirements
- NDA
- CMC Regulatory Affairs
- Drug Development
- Regulatory Filings
- Clinical Development
- Regulatory Strategy Development
- Regulatory Labeling
- Pharmacovigilance
Michael Vandi Summary
- Michael Vandi, based in Boston, MA, US, is currently a Principal Consultant, Regulatory Labeling at Opus Regulatory Inc.. Michael Vandi brings experience from previous roles at AstraZeneca, Alexion Pharmaceuticals, Inc. and Takeda. Michael Vandi holds a Master of Science (M.S.) in Regulatory Affairs @ Northeastern University. With a robust skill set that includes Biotechnology, Quality System, GMP, Quality Assurance, Validation and more. Michael Vandi has 1 emails and 2 mobile phone numbers on RocketReach.
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