Mansi Gupta

Experience

• 

  GB PANT HOSPITAL

  Aug 2018 - Feb 2019

  Research Coordinator
• 

  Biocon Academy

  Mar 2019 - Jul 2019

  Biosciences - KGI Certificate Program

  Experiential learning in Regulatory Sciences (USFDA regulations, 21CFR, ICH Guidelines, CDSCO Filings), R&D, Quality Control, Quality Assurance, Production and Quality Control Microbiology at Biocon Facilities, India.Hands on Training in Pilot Scale Fermentation at BioZeen and Molecular Techniques at ThermoFisher, R&D centre, India.

• 

  Biocon

  Sept 2019 - Dec 2019

  Medical Science Liaison (Metabolics)

  - Strategic Application of scientific and clinical data to support therapeutic and business interests- Literature review specialist- Clinical and Therapeutic support in Diabetes portfolio

• 

  ZEISS Medical Technology

  Dec 2019 - now

  Regulatory Strategy - SaMD, Generative AI and software as medical devices - Clinical study design development and Management- Clinical Dossier preparation for MDR Registration/FDA submissions of SaMD products- Clinical Evaluation & Data Appraisal for AI Products- Clinical data management and source data verification- Innovative Applications research based on AI models- Clinical Publications - MDD to MDR Transition for Class 1 and Class IIa SaMDs- Clinical regulatory document preparation for MDR

  • Project Manager - Clinical & Regulatory Affairs

    Jan 2025 - now

  • Project Lead - Clinical & Regulation Affairs

    Feb 2024 - Feb 2025

  • Clinical Affairs Specialist

    Jan 2023 - Feb 2024

  • Clinical Affairs Associate

    Sept 2020 - Mar 2023

  • Regulatory Affairs Associate

    Dec 2019 - Sept 2020