Niharika Gaddala
Raps Member @Regulatory Affairs Professionals Society (RAPS)
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WORK HISTORY
Raps Member @Regulatory Affairs Professionals Society (RAPS)
EDUCATION
Synergy School of Business
Master of Business Administration (MBA)
Jawaharlal Nehru Technological University
Bachelor of Pharmacy (B.Pharm.), Pharmaceutical Sciences
University of California, Santa Cruz
Clinical Trials & Design Management, Clinical Trials|Regulatory Affairs|Medical devices
ABOUT NIHARIKA GADDALA
Over 8+ years of experience in Regulatory Affairs, Clinical Research and Business Development. • Strong understanding of Clinical Research, Regulations of Drugs and Medical devices. • Experienced in Regulatory filings with FDA and other country specific regulatory submissions of products. • Reviewed and verified reports for accuracy and Regulatory compliance to drive completion of market applications and approvals. • Gathered extensive research information related to marketing applications through navigation of Regulatory submissions and Regulatory documentation systems. • Maintain current thorough knowledge of FDA policies, guidance and industry standards.
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