Rishi Dubey
Senior Regulatory Affairs Specialist @Rd2rx, Llc
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WORK HISTORY
Senior Regulatory Affairs Specialist @Rd2rx, Llc
New Delhi, IN
8 years and 3 month of experience in filing IND, NDA and ANDA submissions in compliance with current US FDA regulation and format | CMC Change controls | Annual Reports | Adverse Drug Experience Reports | Document preparation as per eCTD requirements for m1, m2 and m3 | Prepare and review documents for PAS, CBE-30, CBE-0, Annual Reports and PADERs | Prepare and review response for Information Requests, Complete Response and DR letters Reach me at r••••••••@gmail.com
SKILLS
ABOUT RISHI DUBEY
My Self Rishi Anand Dubey B pharm i have 6 year 9 month experience in Drug Regulatory…
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