Michael Bui Email & Phone Number
Senior Vice President, Global Regulatory Affairs @ Pyxis Oncology
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Michael Bui Location
- Boston, MA, US
Michael Bui Work
- 2022 -now Senior Vice President, Global Regulatory Affairs @
- 2020 -now President and Principal Consultant @
- 2019 -now Adjunct Faculty, Regulatory Affairs and Health Policy Program @
- 2019 -2023 Industry Representative, FDA Pharmacy Compounding Advisory Committee (CDER) @
- 2020 -2021 Senior Vice President, Global Regulatory Affairs @
- 2011 -2020 Adjunct Lecturer, Regulatory Affairs for Drugs and Biologics Program @
- 2019 -2020 Vice President, Regulatory Affairs @
- 2017 -2019 Vice President, Head of Regulatory Affairs, Immuno-Oncology and Rare Diseases @
- 2016 -2017 Director, Global Regulatory Lead, Immuno-Oncology @
- 2014 -2016 Director, Global Regulatory Affairs, Internal Medicine Group (Multiple TAs and Biosimilars) @
- 2011 -2016 Adjunct Assistant Professor of Epidemiology @
- 2010 -2014 Global Regulatory Strategist, Oncology @
- 2007 -2010 Drug Regulatory Affairs Specialist, Pharma Development Regulatory @
- 2006 -2007 Global Labeling Strategist, Global Labeling and Promotion Compliance @
- 2006 -2006 Medical Writer, Oncology Clinical Development @
- 2005 -2006 Regulatory Intelligence Analyst @
Michael Bui Education
- Columbia University College of Dental Medicine
Doctor of Dental Surgery (Doctor of Dental Surgery, Dental Medicine)
- University at Buffalo School of Law
Juris Doctor (Juris Doctor, Certificate in Intellectual Property & Technology, Law)
- Columbia University Mailman School of Public Health
Master of Public Health (Master of Public Health, Public Health)
- University of California, Berkeley
Bachelor of Arts (Bachelor of Arts, Molecular Biology)
- Veterans Affairs Medical Center - Brooklyn
(General Practice Residency)
Michael Bui Skills
- PowerPoint
- Clinical Trials
- Medical Writing
- Social Media
- Public Speaking
- CRO
- Epidemiology
- Health Economics
- Food
- Hardware Diagnostics
- Neuroscience
- Neurology
- Infectious Diseases
- Clinical Research
- Regulatory
- CTMS
- Biotechnology
- Advisory
- Regulatory Affairs
- Immunology
- Healthcare
- Life Sciences
- Hematology
- Medical Devices
- Strategy
- Editorial
- Regulatory Requirements
- Pharmacovigilance
- Public Health
- Drug Discovery
- Molecular Biology
- Lifesciences
- Protocol
- Medicine
- Oncology
- Marketing
- GCP
- Drug Development
- Clinical Development
- Pharmaceutics
- Customer Service
- Biologics
- Cancer
- Regulatory Submissions
- Pharmacology
- Diabetes
- Vaccines
- Management
- Emd
- Informatics
- Pharmaceutical Industry
- Biochemistry
- Technology Transfer
- GLP
- Biomarkers
- FDA
- R&D
- Sop
- Commercialization
- Medical Affairs
- Biopharmaceuticals
- Microsoft Excel
- Project Management
Michael Bui Summary
- Michael Bui, based in Boston, MA, US, is currently a Senior Vice President, Global Regulatory Affairs at Pyxis Oncology. Michael Bui brings experience from previous roles at E&A Beacon Regulatory Solutions, LLC, Massachusetts College of Pharmacy and Health Sciences, FDA and Kadmon, a Sanofi Company. Michael Bui holds a Doctor of Dental Surgery in Doctor of Dental Surgery, Dental Medicine @ Columbia University College of Dental Medicine. With a robust skill set that includes PowerPoint, Clinical Trials, Medical Writing, Social Media, Public Speaking and more. Michael Bui has 4 emails and 2 mobile phone numbers on RocketReach.
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