Sheetal Gaiki is an Associate Director in CMC Regulatory Submissions, Janssen Pharmaceuticals (Johnson & Johnson) and is based in NJ. She has more than 20 years of industry experience in early to late phase development of biologics, combination products and small molecules. In her current role, Sheetal is responsible for developing content strategy and delivering biologic and combination product clinical and marketing application dossiers for global submissions and has led dossier development for multiple globally approved programs.
Sheetal holds a master’s in pharmacy from University of Pune, India and is an active member of multiple external organizations. She is involved in multiple internal and external efforts related to CMC data standardization and modernization of regulatory information management using emerging technologies. She is a member of the core team for the CMC Data Exchange platform currently being developed by Accumulus Synergy, a non-profit company founded in 2020 which seeks to advance innovative solutions that can reduce regulatory review times and transform global data exchange. She has co-created a CMC Content Model to facilitate optimized data exchange and is contributing to the platform's design.