Sujata Kulkarni

Sujata Kulkarni is an experienced professional in regulatory affairs, currently serving as Manager I - Regulatory Affairs and Principal Executive Consultant II - CMC RA - HQ Submissions at Syner-G BioPharma Group since June 2021. Responsibilities include the preparation and submission of CMC dossiers, collaboration with clients and partners for change management compliance, and management of CMC documentation throughout the product lifecycle. Prior experience includes working as Deputy Manager Regulatory Affairs at Anthem Biosciences Private Limited, where Sujata focused on regulatory affairs for drug discovery and healthcare product manufacturing, and Quality Officer roles at Micro Labs Ltd. and Green Chem. Educational qualifications include a Master's degree in Microbiology and Immunology from Kuvempu Vishwavidyanilaya, a Bachelor of Science in Biotechnology from Gulbarga University, and certifications in International Drug Regulatory Affairs and Good Manufacturing Practices from Royed Institutions.