Ashwini Kulkarni

Ashwini Kulkarni is a Regulatory Affairs professional with over 15 years of experience. Ashwini began their career in 2005 as a Regulatory Affairs professional and a Formulation research and development scientist at Dr. Reddy's Laboratories Ltd. In 2011, they pursued an MSc in Pharmacology at the Department of Pharmacology in Oxford. In 2013, Ashwini joined MSD as a Regulatory CMC scientist. Ashwini then moved to EMMC (Leader biomedical) in 2014 as a Regulatory Affairs Officer. In 2017, they became a Self-employed Regulatory Affairs professional and a Senior Consultant Regulatory affairs at Qserve Group. Her role at Qserve Group included Regulatory Affairs activities such as pharmaceutical products, medical devices class IIa/IIb/III implantable devices, combination products, borderline devices/products, human and animal tissue based products, Regulatory project management, and early stage development to post-market submission activities. Ashwini is currently an Associate Director Regulatory CMC at LAVA Therapeutics N.V.

Ashwini Kulkarni's education history consists of a Bachelor of Pharmacy degree from Bombay College of Pharmacy (2001-2005), a Master of Science in Pharmacology from the University of Oxford (2011-2012), and a HMX Fundamentals course from Harvard Medical School (2021). Ashwini also attended JSM College (1999-2001) and completed a course at the World Intellectual Property Organization (WIPO) in 2009.