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Shreena Patel Location
New York, NY, US
Shreena Patel Work
Associate Director @ (March 2019 - Present)
Senior Manager @ (September 2013 - March 2019)
Project Manager @ (January 2007 - March 2019)
Regulatory Affairs Specialist @ (January 2007 - January 2010)
Shreena Patel Education
Sambalpur University, Sambalpur
(Pharmacy)
1996-2001
Shreena Patel Skills
21 CFR Part 11
ANDA
Biopharmaceuticals
CMC
CMC Regulatory Affairs
CRO Management
Change Control
Clear Vision
Clinical Trials
Common Technical Document (CTD)
Communication
Conflict Resolution
Corrective and Preventive Action (CAPA)
Cross-functional Team Leadership
Director level
Drug Development
Electronic Submissions
FDA
Flawless Execution
GMP
Generic Programming
Generics
Good Clinical Practice (GCP)
Investigational New Drug Application (IND)
Issue Management
Leadership
Mitigation Strategies
New Drug Application (NDA)
Organizational Initiatives
Pharmaceutical Industry
Pharmaceuticals
Pharmaceutics
Presentations
Product Lifecycle Management
Project Management
Quality Assurance
Quality Systems
Regulatory Affairs
Regulatory Agencies
Regulatory Compliance
Regulatory Filings
Regulatory Operations
Regulatory Requirements
Regulatory Strategy
Regulatory Submissions
Regulatory Training
Strategic Thinking
Technical Reviews
cGMP
eCTD
Sop
Shreena Patel Summary
Shreena Patel, based in New York, NY, US, is currently a Associate Director at Amneal Pharmaceuticals. Shreena Patel brings experience from previous roles at Amneal Pharmaceuticals and Interpharm. Shreena Patel holds a 1996 - 2001 Sambalpur University, Sambalpur. With a robust skill set that includes 21 CFR Part 11, ANDA, Biopharmaceuticals, CMC, CMC Regulatory Affairs and more. Shreena Patel has 2 emails and 1 mobile phone numbers on RocketReach.
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