Meera Sharif
Regulatory Associate @Eli India
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WORK HISTORY
Regulatory Associate @Eli India
About 1 Year + experience as Regulatory Research analyst in Eli India, which made a project to give instant information over new drugs, Regulatory launch, Patent expiry, clinical trials and exclusivity information of the drugs for both pharmaceutical companies and Biotech companies. Key knowledge areas are as follows;In-depth knowledge over Regulatory Authorities such as USFDA, EMA, Health Canada, TGA, PMDA, MHRA and CDSCOTremendous Knowledge on Regulatory submissions such as IND’A, NDA, sNDA, BLA, sBLA, ANDA, NDS, MAA and Bio similarGood knowledge of US, Europe Drug Master FilesGood knowledge of good Manufacturing Practices (cGMP).Well versed with ICH Quality guidelines, e-CTD, CTD & ACTD formats.Good knowledge on European dossier procedures CP, MRP, NP, DCPGood knowledge on Generic & Prescription Drug user Fees Acts GDUFA, PDUFAJOB PROFILEPreparation and review of the regulatory launch information as per the current prescribed guidelines of the respective regulatory authorities.Data collection from various regulatory authoritiesReview of Regulatory authority’s documents Preparation of various standard operating procedures for various countriesReview of SmPC and labelling information.
EDUCATION
Andhra University
Sri Sai Srinivasa Pg&Degree College,Parwada Junction,Vishakapatnam.
Suriya Vidyalayam
Ssc
Santhinikethan Degree college
SNDC College
ABOUT MEERA SHARIF
Dream is eCTD filing
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