Birju Patel Email & Phone Number
Director CMC and Regulatory Affairs Operations @ Voisin Consulting Life Sciences (VCLS)
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Birju Patel Location
- New York, NY, US
Birju Patel Work
- Director CMC and Regulatory Affairs Operations @ (January 2024 - Present)
- Director CMC and Regulatory Affairs @ (January 2022 - January 2024)
- Associate Director, CMC and Regulatory Affairs @ (January 2020 - December 2021)
- Senior Regulatory Affairs Project Manager @ (June 2015 - December 2019)
- Supervisor, Regulatory Affairs CMC Consultant @ Genpact Pharmalink (June 2013 - June 2015)
- Regulatory Affairs CMC Associate @ Unigene Laboratories, Inc. (January 2012 - June 2013)
- Senior Analytical Development Associate @ Unigene Laboratories, Inc. (June 2011 - June 2013)
- Quality Control Associate @ Unigene Laboratories Inc (March 2008 - June 2011)
- Quality Control Technician @ International Trading Pharmaceutical Laboratories (December 2005 - December 2007)
Birju Patel Education
- Northeastern University
Masters (Drugs, Biologics, and Medical Device Regulatory Affairs)
2010-2011 - Rutgers University
Bachelors (Cell Biology and Neuroscience)
2000-2005
Birju Patel Skills
- FDA Regulations
- ICH Guidelines
- cGMP Compliance
- HPLC Assays
- Dissolution Method Development and QC Testing
- MS Office Suite
- ANOVA
- GMP
- FDA
- Wet Chemistry
- HPLC
- Assay Development
- Dissolution
- Validation
- Pharmaceutical Industry
- Biopharmaceuticals
- GLP
- Sop
- Microsoft Office
- Regulatory Affairs
- Analytical Chemistry
- Quality Control
- Pharmaceutics
- UV/Vis
- Quality Assurance
- Quality System
- Development
- Windows
- eCTD
- Microsoft Word
- Testing
- Analytical Skill
- Drug Development
- USP
- Raw Material Testing
Birju Patel Summary
- Birju Patel, based in New York, NY, US, is currently a Director CMC and Regulatory Affairs Operations at Voisin Consulting Life Sciences (VCLS). Birju Patel brings experience from previous roles at B&H Consulting Services, Inc. and Genpact Pharmalink. Birju Patel holds a 2010 - 2011 Masters in Drugs, Biologics, and Medical Device Regulatory Affairs @ Northeastern University. With a robust skill set that includes FDA Regulations, ICH Guidelines, cGMP Compliance, HPLC Assays, Dissolution Method Development and QC Testing and more. Birju Patel has 3 emails and 1 mobile phone numbers on RocketReach.
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