Jobs at Kailera Therapeutics, Inc.

Leads global regulatory strategy and execution for investigational and future commercial products. Oversees IND, CTA, NDA, MAA, amendments, agency responses, regulatory intelligence, submission quality, compliance, and cross-functional collaboration across clinical, safety, CMC, and regulatory operations teams. Develops regulatory guidance, monitors global requirements, manages risk, and contributes to SOPs and internal processes.

Leads global regulatory labeling and advertising promotion activities across the product lifecycle. Responsibilities include developing and maintaining prescribing information, patient labeling, medication guides, IFUs, carton labeling, and promotional materials; guiding FDA compliance; supporting labeling negotiations and updates; evaluating claims; participating in MLR review; monitoring regulatory developments; and maintaining related SOPs and governance processes.

Lead global clinical data management strategy across all clinical development phases. Oversee data quality, eCRF builds, edit checks, integrations, reconciliations, data cleaning, database locks, submission readiness, regulatory compliance, CRO oversight, and inspection readiness. Build and develop a high-performing data management organization, establish governance and quality metrics, manage resources, and represent Data Management in cross-functional initiatives.

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.