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Sheetal Gaiki
Johnson & Johnson Pharma R&D LLC
Associate Director
Sheetal Gaiki is an Associate Director in CMC Dossier Development & Operations, Johnson & Johnson Innovative Medicine 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. She holds a master’s in pharmacy from University of Pune, India.
Sheetal is also 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 an integrated CMC Content Model to facilitate optimized data exchange, is co-leading HL7 BR&R's Pharmaceutical Quality (Industry Use Case) project. At J&J, Sheetal is involved in driving the efforts for automated structured authoring of various sections of the CMC dossiers via content modeling, data standardization, and use of GenAI based applications. She is actively collaborating on various cross-functional initiatives geared towards data-centric submissions through intelligent automation using scalable and sustainable data strategy, while maintaining compliance, and ensuring that any changes made are complementary and aligned with efforts within various industry and/or HA initiatives.
Sheetal is also 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 an integrated CMC Content Model to facilitate optimized data exchange, is co-leading HL7 BR&R's Pharmaceutical Quality (Industry Use Case) project. At J&J, Sheetal is involved in driving the efforts for automated structured authoring of various sections of the CMC dossiers via content modeling, data standardization, and use of GenAI based applications. She is actively collaborating on various cross-functional initiatives geared towards data-centric submissions through intelligent automation using scalable and sustainable data strategy, while maintaining compliance, and ensuring that any changes made are complementary and aligned with efforts within various industry and/or HA initiatives.