K. Sunil Kumar
Manager at Slayback Pharma LLC
- Role
- Manager Cmc Us at Slayback Pharma
- Location
- Hyderabad, IN
- LinkedIn followers
- 500 followers
About K. Sunil Kumar
Preparation and Submission of high quality NDA and ANDA dossiers to USFDA. Filing of dossiers to EMEA and other markets. Good Knowledge in ICH Quality guidelines & knowledge in Compiling 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. Maintain the Regulatory Life cycle submissions (Amendments,Supplements,Annul reports & PADERs).
Experience
Manager Cmc Us
Mar 2018 — Present
Education
Jawaharlal Nehru Technological University
B. Pharmacy, pharma
2006 — 2010
PRIST University - India
M.Pharm Pharmaceutics
in Rao’s Jr College
Inter
Nagarjuna High school
SSC
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