Vandana Gupta
Regulatory Affairs @Merit Organics Ltd
Signup · Get unlimited contacts
WORK HISTORY
Regulatory Affairs @Merit Organics Ltd
Borivali, IN
As a Junior Regulatory Affairs, I played a pivotal role in ensuring compliance and quality of pharmaceutical products. My key responsibilities included:Document Verification and Formatting- Verified factory documents for accuracy and completeness- Converted documents to CTD (Common Technical Document) and ACTD (Asian CTD) formats as per country-specific requirementsDocument Types Verified- Protocols- Validation reports- DMF (Drug Master File)- BMR (Batch Manufacturing Record)- AMV (Analytical Method Validation)- Specifications- COA (Certificate of Analysis)- PDR (Pharmaceutical Development Report)- Stability studiesAdditional Responsibilities- Conducted artwork and literature checks to ensure accuracy and compliance- Arranged registration samples for submission to regulatory authorities- Ensured the quality of company products and maintained high-quality documentationBy effectively managing these responsibilities, I contributed to the maintenance of high-quality products and compliance with regulatory requirements
EDUCATION
University of Mumbai
Bachelor of Pharmacy - BPharm
ABOUT VANDANA GUPTA
I’m currently working in the Regulatory Affairs department at Merit Organics, where I…
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.