Teams at Kailera Therapeutics, Inc.

Leads regional and global cross-functional teams in planning, preparing, and delivering compliant drug marketing authorization submissions. Owns integrated submission plans, timelines, resources, dashboards, governance updates, risk mitigation, project delivery, and submission-process best practices. Collaborates with regulatory, clinical, quality, CMC, medical writing, and technical operations teams to manage complex late-stage drug development programs and ensure NDA, BLA, and MAA submissions are completed on time, within scope, and within budget.

Leads development and commercialization of drug-device combination products, including autoinjectors, pre-filled syringes, and multidose pens. Manages requirements, design controls, risk management, verification and validation, human factors, design transfer, regulatory submissions, vendors, test laboratories, and Design History File deliverables. Coordinates cross-functionally with CMC, quality, regulatory, manufacturing, clinical, commercial, and supply chain teams while ensuring compliance with applicable FDA, ISO, IEC, and ASTM standards.