Mayuri Dabholkar

Background

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!