Sheetal Gaiki
Sr Principal Sci II, Johnson & Johnson
Sheetal Gaiki is a Sr Principal Scientist II, at Johnson & Johnson with over 20 years of experience in biologics, combination products, and small molecule development and regulatory dossiers. She leads digitalization initiatives within CMC and Regulatory space, focusing on GenAI, structured content, and enterprise data management, while shaping innovative technology solutions. Sheetal serves as a co-lead on HL7 BR&R’s Pharmaceutical Quality (Industry) project and represents J&J in cross-industry consortia (Regulatory IT, ICH M16 (SPQS)). Her work emphasizes collaboration across teams to align and advance strategic company and industry initiatives.