Shweta Rao

Regulatory Affairs @Amol Pharmaceuticals Pvt Ltd

Jaipur, IN

Job responsibilities included:• Preparation of dossiers as per CTD format for regulated market & ACTD format for ASEAN market and country-specific format for ROW market. • Preparation of response to queries received from regulatory authorities/clients.• Coordination with QA, QC and Production department.• Preparation and Maintenance of tracker for on-going project status, organizational accreditations status and dossier & query status.• Preparation, Compilation and Reviewing of Clinical and Non-clinical Summary.• Review of CMC documents in accordance with specific guidelines.• Preparation of Administrative documents and draft of legal documents.Experienced in:• Countries/Market: Canada, Australia, South Africa, UK, LATAM, US, GCC, Peru, UAE, Srilanka, Ecuador, Singapore & ROW Market • Product: Pharmaceuticals, Nutraceuticals and Medical devices.

Saint Michael Senior Secondary School

Schooling

NIMS University

Bachelor of Pharmacy - BPharm