Prakash Patel Email & Phone Number
Director, Global Regulatory Lead (Submission Strategy and Regulatory Intelligence) @ iTeos Therapeutics
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Prakash Patel Location
- Boston, MA, US
Prakash Patel Work
- 2021 -now Director, Global Regulatory Lead (Submission Strategy and Regulatory Intelligence) @
- 2021 -now Adjunct Professor – Global Regulatory Affairs @
- 2017 -2021 Sr. Manager, Global Regulatory Affairs @ Sumitomo Dainippon Pharma Oncology
- 2011 -2017 Manager Regulatory Lead @
- 2006 -2011 Regulatory Affairs Specialist @
Prakash Patel Education
- Northeastern University
Master of Science in Regulatory Affairs for Drugs (Biologics, and Medical Devices, Regulaotry Affairs)
2015-2016 - University of Maryland Eastern Shore
Bachelor's Degree (Biology, General)
2001-2004
Prakash Patel Skills
- Regulatory Submissions
- Regulatory Affairs
- eCTD
- IND
- FDA
- Regulatory Requirements
- Pharmaceutical Industry
- Clinical Trials
- Pharmaceutics
- NDA
- BLA
- Clinical Research
- CRO
- GMP
- Pharmacovigilance
- ANDA
- CMC
- GLP
- Protocol
- Therapeutic Areas
- ICH guidelines
- Drug Safety
- 21 CFR Part 11
- Clinical Development
- GCP
- Validation
- SOP
- Regulatory Filings
- Drug Development
- CAPA
- Oncology
- Lean Six Sigma
- Quality Control
- Life Sciences
- Regulatory Operations
- Biopharmaceuticals
- Biotechnology
- Medical Devices
- Quality Assurance
- Leadership
- Cross-functional Team Leadership
- Cross-training
- Inspection Readiness
- Project Management
- Management
- Change Control
- CPP (Certificate of Pharmaceutical Product)
- OPDP (Office of Prescription Drug Promotion)
- CTMS
- Technology Transfer
- Cross Functional Team Leadership
- Marketing
- Opdp Office of Prescription Drug Promotion
- Cpp Certificate of Pharmaceutical Product
- Cross Training
- Strategic Planning
- Microsoft Excel
- Financial Analysis
- Solutions
- Event Planning
- CPP
- Opdp
Prakash Patel Summary
- Prakash Patel, based in Boston, MA, US, is currently a Director, Global Regulatory Lead (Submission Strategy and Regulatory Intelligence) at iTeos Therapeutics. Prakash Patel brings experience from previous roles at Northeastern University, Sumitomo Dainippon Pharma Oncology, Roche and Cadista Pharmaceuticals. Prakash Patel holds a 2015 - 2016 Master of Science in Regulatory Affairs for Drugs in Biologics, and Medical Devices, Regulaotry Affairs @ Northeastern University. With a robust skill set that includes Regulatory Submissions, Regulatory Affairs, eCTD, IND, FDA and more. Prakash Patel has 3 emails and 3 mobile phone numbers on RocketReach.
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