Nikhila Hinge

Experience

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  Clariant

  Jan 2021 - May 2023

  Regulatory Affairs Associate

  • Monitored and collected data for regulatory changes for international markets (FDA, Health Canada, MHRA, EMA) and incorporated the changes in Technical Master File for Class II medical devices• Authored and reviewed 510(k) documentation by identifying predicate devices, establishing substantial equivalence while updating SOPs for improved product compliance with ISO 14971 & ISO 13485• Reviewed and provided guidance on product labeling, coordinated and supported clinical trial activities, tracked study timelines, and assisted in the preparation and maintenance of essential trial documentation from initiation to completion Show less

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  Bastyr University

  Nov 2023 - Dec 2023

  IRB Member - Non Affiliated Scientist
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  Merck

  Jun 2024 - Aug 2024

  Global Regulatory Affairs Intern - Oncology

  • Led Project ORBIS, coordinating with 10+ global regulatory liaisons to develop and execute INDs / pre-IND with a 25% faster approval timeline compared to industry standards• Provided independent unbiased medical and scientific review and recommendations for 2 Merck Investigator Study Program (MISP) Belzutifan - Bevacizumab protocols• Engaged in drafting Clinical Trial Application for Belzutifan for smooth implementation for Clinical Trials in the USA• Authored and coordinated responses to over 100+ complex inquiries from FDA, MHRA, and TGA, leading to a 40% reduction in query resolution time and enhancing regulatory approval rates• Provided exceptional support to Global Regulatory leads by executing project work as needed, demonstrating strong organizational and time management skills to meet deadlines and achieve quality outcomes• Acquired hands-on experience with NDA, sNDA, and CTA submissions, contributing to a 30% increase in submission efficiency and accuracy Show less

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  The Sports Institute at UW Medicine

  Jan 2025 - now

  Regulatory Affairs Intern - SaMD