Dr. Sandhya Kumaraswamy

Dr. Sandhya is an experienced Quality and Regulatory affairs professional in the Bio-Pharmaceutical field with more than 17 years of experience. She holds a PhD in Biochemistry and post-doctoral research in cancer biology from USA.

She has successfully led and managed national and international regulatory inspections and approvals, established robust systems for technology transfers, implemented learning and document management systems. She enabled the CMC development of biotherapeutics and biosimilars by combining her rich technical expertise in bio-analytics, product characterization and regulatory strategy. She was instrumental in leading teams successfully facilitating the compilation of product dossiers, managing regulatory queries, and expediting approvals in both developed and emerging markets.

She has worked in multiple leadership roles at the Biologics unit of Dr. Reddy’s, that include bioanalytical characterization, quality control, quality assurance and regulatory affairs for more than a decade and handled teams successfully.

Currently, Dr. Sandhya serves as an Independent Consultant specializing in quality and regulatory affairs, learning and development advisory to Bio-pharma clients. She is also an adjunct professor at CBIT, Hyderabad and serves on the ‘Board of Studies’ facilitating curriculum design, training and mentoring for biotechnology programs.