Namrata Bhusari
Senior Officer - Regulatory Affairs @Indoco Remedies Ltd
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WORK HISTORY
Senior Officer - Regulatory Affairs @Indoco Remedies Ltd
Managing regulatory submissions and product registrations across South East Asia (Sri Lanka, Myanmar, Nepal), LATAM (Chile, Colombia), and WHO-PQTm markets.Preparing, reviewing, and submitting dossiers in CTD/ACTD/country-specific formats for new product registrations, renewals, and variations.Coordinating with cross-functional teams for timely provision of regulatory documents.Handling regulatory queries from health authorities and providing scientific justifications.Supporting WHO Prequalification (PQTm) submissions, site registration processes, and global tenders.Filed post-approval variations and product renewals.Tracking and ensuring compliance with regional regulatory guidelines to expedite approvals.Co-ordination & meetings with customers and their regulatory teams.
EDUCATION
Dr.L.H. Hiranandani college of pharmacy
Bachelor of Pharmacy - BPharm
C.U.Shah College of Pharmacy
Master's degree
ABOUT NAMRATA BHUSARI
Regulatory affairs- Executive at Meyer Organics Pvt Ltd Postgraduate (MPharm) in…
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