Nansi Shrivastava

Experience

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  Apollo Hospitals

  Jul 2018 - Aug 2018

  Trainee Pharmacist

  • Prescription Checking• Auditing• Stock monitoring

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  Jubilant Biosys Limited

  Jan 2019 - Jun 2019

  Project Trainee

  • 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

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  Cliantha Research Limited

  Jun 2019 - Dec 2021

  Research Associate

  • 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

• 

  United Biotech India Pvt.Ltd.

  Jun 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

  • Drug regulatory affairs and International Business Development Executive

    Jan 2022 - May 2023

  • Trainee Drug Regulatory Affairs

    Jun 2022 - Dec 2022
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  Shivalik Rasayan Ltd

  Apr 2023 - now

  Regulatory Affairs Executive

  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