Priya Trivedi
Regulatory Affairs (Api) @TOPRA - The Organisation for Professionals in Regulatory Affairs
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WORK HISTORY
Regulatory Affairs (Api) @TOPRA - The Organisation for Professionals in Regulatory Affairs
Mumbai, IN
Prepared and submitted DMFs and Letters of Authorization (LoA) in compliance with EMA and USFDA requirements.2. Compiled Module 1 (Summary of Changes) and Module 3 (3.2.S) documentation in accordance with ICH guidelines.3. Supported with post-approval activities such as CEP revisions, amendments, and implementation of changes based on new regulatory requirements.4. Maintained regulatory query tracker documenting agency interactions (USFDA, EDQM, ROW) & assisted in query response preparation ensuring alignment with specified agency requirements.5. Handling NextGen eCTD software to compile documents in accordance with ICH CTD granularity. Performed document validation using Lorenz e-validator, ensuring accurate formatting.
EDUCATION
Universal School Ghatkopar
Cambridge IGCSE, Science
SHOBHABEN PRATAPBHAI PATEL SCHOOL OF PHARMACY & TECHNOLOGY MANAGEMENT
Bachelor's , Pharmacy
International Baccalaureate (IB)
International Baccalaureate Diploma Programme (IBDP), Science
Technological University Dublin
Master's, Pharmaceutical Quality Assurance & Regulations
ABOUT PRIYA TRIVEDI
I’m a graduate student with an MSc in Pharmaceutical Quality Assurance and Regulatory Affairs degree from Technological University Dublin, with a Bachelor’s in Pharmacy from NMIMS Mumbai. I bring hands-on experience from internships at Cipla and Harman Finochem, where I worked on real-world CTD dossier preparation (Module 3.2.S and 1), GMP compliance, regulatory documentation, and query handling for global markets (USFDA, EDQM, ROW).Seeking opportunities in Regulatory Affairs and Quality Assurance. My interests include global submissions and filings, regulatory compliance, auditing, and change management, enabling me to support the efficient lifecycle management of drug products
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