Regulatory Affairs Executive

• Apr 2023 - Present

Prepare and / or review submissions to FDA for a variety of dosage forms (solid oral, liquids, topical semisolids and injectables) in eCTD format (e.g. DMFs, ANDS, NDS, ANDA, NDAs, S/NDSs, DINs, CTAs, NCs, INDs, provincial formulary submissions etc.) for the successful registration of drug products for domestic and international markets. • Prepare submissions in eCTD, CTD , ACTD and Regional format which involves full understanding of the use of Adobe Acrobat to create bookmarks and links. • Prepare written responses to deficiency letters from regulatory agencies in the stated time frame. • Prepare and file post approval submissions for FDA • Maintain approved product monographs to comply with regulatory bodies • Maintain approved drug products for FDA (Annual Report) and TPD (Annual Drug Notification). • Review and approve various product labeling components and marketing materials. • Review internal documentation (master batch records, specifications, labeling, product monographs) for adherence to regulatory guidelines. • Assist in global drug product registrations. • Maintain current awareness of regulatory guidelines (Health Canada, FDA, ICH, European Medicines Agency - EMeA, Therapeutic Goods Administration –TGA Australia, etc.). Show less

Drug regulatory affairs and International Business Development Executive

• Jan 2022 - May 2023

• Prepare and / or review submissions to FDA for a variety of dosage forms (solid oral, liquids, topical semisolids and injectables) in eCTD format (e.g. DMFs, ANDS, NDS, ANDA, NDAs, S/NDSs, DINs, CTAs, NCs, INDs, provincial formulary submissions etc.) for the successful registration of drug products for domestic and international markets.• Prepare submissions in eCTD, CTD , ACTD and Regional format which involves full understanding of the use of Adobe Acrobat to create bookmarks and links. • Prepare written responses to deficiency letters from regulatory agencies in the stated time frame.• Prepare and file post approval submissions for FDA • Maintain approved product monographs to comply with regulatory bodies• Maintain approved drug products for FDA (Annual Report) and TPD (Annual Drug Notification).• Review and approve various product labeling components and marketing materials.• Review internal documentation (master batch records, specifications, labeling, product monographs) for adherence to regulatory guidelines.• Assist in global drug product registrations.• Maintain current awareness of regulatory guidelines (Health Canada, FDA, ICH, European Medicines Agency - EMeA, Therapeutic Goods Administration –TGA Australia, etc.). Show less

Trainee Drug Regulatory Affairs

• Jun 2022 - Dec 2022

Research Associate

• Jun 2019 - Dec 2021

• Preparation and planning of trial related activities. • Coordination with study personnel and other departments for trial related matters. • Responsible for accountability of trial documents at clinic. • Handling and management of trial related activities along with Co-Investigator and Principal investigator. • Responsible for timely conduct of trial. • Protocol and SOP training to the study personnel for better quality of trial. • Responsible for updating to sponsor and IEC for trial related activities along with sub investigator and Principal investigator. • To check and review the raw data. • Handling of investigational product as per trial. • Other clinical trial related activities, as applicable Show less

Project Trainee

• Jan 2019 - Jun 2019

• Experimental Data compilation • Spitting , weighing ,Handling of final product • Quality and packaging monitoring of product • Sample preparation, Fluid induction decay of NMR spectroscopy. • Sample preparation of LC-MS instrument • Experimental Data compilation • Spitting , weighing ,Handling of final product • Quality and packaging monitoring of product • Sample preparation, Fluid induction decay of NMR spectroscopy. • Sample preparation of LC-MS instrument

Trainee Pharmacist

• Jul 2018 - Aug 2018

• Prescription Checking • Auditing • Stock monitoring • Prescription Checking • Auditing • Stock monitoring