Sunil Kumar Kurupati
Senior Manager @Bristol Myers Squibb
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WORK HISTORY
Senior Manager @Bristol Myers Squibb
Hyderabad, IN
EDUCATION
Jawaharlal Nehru Technological University
B. Pharmacy
PRIST University - India
M.Pharm Pharmaceutics
in Rao’s Jr College
Inter
Nagarjuna High school
SSC
ABOUT SUNIL KUMAR KURUPATI
Preparation and Submission of high quality NDA, 505(b2) and ANDA dossiers to USFDA.Handling products globally for product life cycle management. Expertise in defining the regulatory strategies and seeking approvals from HAs.Maintain the Regulatory Life cycle submissions (Amendments, Supplements, Annul reports & PADERs).Evaluating the change controls and defining the categories the change impact on drug product quality, safety and efficacy. Knowledge on drug product labelling. Knowledge in Compiling the Dossiers in eCTD/CTD/NeeS country specific formats (EU, Emerging Markets like Canada and Australia agencies).Preparation & Compilation of technical packages.Handling of client projects based their requirements to global markets.
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