Mayuri Dabholkar

About Mayuri Dabholkar

With a background in Regulatory Affairs and Quality Assurance, I specialize in ensuring compliance while driving innovation in biopharma and medical devices. My experience spans IND/CTA submissions, IRB processes, CMC documentation, and clinical study compliance, allowing me to support regulatory strategy from early development through approval. At Virufy, I contribute to regulatory-compliant research proposals, IRB documentation, and funding initiatives for AI-driven COPD diagnostics. Previously, at Seagen, I worked on CMC regulatory submissions and Health Authority responses, collaborating cross-functionally to ensure accuracy and compliance. My quality assurance experience at uHealth GmbH provided me with a strong foundation in industry regulations and standards. I am passionate about bridging the gap between regulatory requirements and scientific innovation, ensuring that groundbreaking therapies reach patients efficiently and compliantly. Always open to networking and new opportunities in regulatory affairs! Let’s connect!

Experience

1. Regulatory Affairs Associate

   Virufy

   Aug 2024 — Present

   Virufy is a robust nonprofit research organization developing a smartphone app to diagnose COVID-19 and other respiratory diseases (Chronic Obstructive Pulmonary Disease) through breathing sound analysis.• Authored regulatory-compliant research proposals and grant applications, including Institutional Review Board (IRB) documentation, for projects focused on COPD diagnostic advancements.• Proactively sourced and evaluated funding opportunities from government agencies, private foundations, and other key stakeholders to support research initiatives.• Designed and developed clinical research questionnaires, ensuring strict adherence to regulatory guidelines and alignment with both research and compliance objectives.

Education

• University of Mumbai

  Bachelor's degree

• Universität Hohenheim

  Master's degree

• University of Washington

  Master's degree