Dr. Vaibhav Kulkarni

Dr. Vaibhav Kulkarni

Award-winning Regulatory Affairs leader with 26 years of extensive experience in handling regulations in all Healthcare categories such as Drugs, Medical Devices and Food (specialized products in the Nutraceutical categories) in India and South East Asian countries. Experience in overseeing all regulatory matters, strategic execution, supporting various products and projects, clinical research, innovation, drug safety and pharmacovigilance. Strong knowledge of scientific, legal, and business issues along with proven expertise in ensuring regulatory support for existing products with respect to product changes/modifications, labeling, and promotional material review and approval.

Key Highlights:

• Provided strategic direction and leadership to the team as Senior Director and Senior Leadership Team Member – Regulatory Affairs at Abbott Nutrition.
• An active member of various industry bodies like FICCI, CII & PFNDAI. Also, on the board of Consumer Complaint Council at Advertising Standards Council of India (ASCI), HADSA and International Life Science Institute (ILSI).
• Played a major role in shaping the Infant Regulation & Food Categorization Regulation in India as an industry expert on Specialized nutrition.
• Won Global President Award six times consecutively and bagged many Leadership Awards across the entire career.
• Instrumental in paving the medical device law in India as a steering committee member for the DCGI,
• Awarded " Honoris Causa (Honorary Doctorate) by United Nations, Department of Economics and Social Affairs.
• Felicitated with "Rashtriya Ashoka Samman" by the Ministry of Corporate Affairs.
• Felicitated with “International Peace Achievement Award” by International Peace Achievement Award Council for my role in Healthcare and Nutrition Industry.
• Recipient of “J & J Regulatory Excellence Award in Asia Pac for Quarter 4 (2006) & Quarter 1 (2007)”. Award function held at Singapore. 
• Recipient of “Regulatory Affairs Leadership Award” from Abbott Quality & Regulatory (AQR) for Shaping the regulations for Lactose free IMS.
• Recipient of the scholarship, “Lady Tata Memorial Trust” in India for the entire Research Project during P.G/ Doctorate years.
• Received “Young Scientist of the year” award for the year 2000 – 2001 by the Life Science Society, Mumbai.