Teams at KMR Search Group

Lead EU regulatory strategy and execution for inflammation and musculoskeletal development programs. Support clinical development and MAA activities, manage submissions and agency interactions (EMA and national agencies), monitor EU legislation, liaise with business partners and alliance teams, and act as the EU regulatory subject-matter resource to drive timely program progression and compliant product approvals.

Lead regulatory strategy and interactions with FDA and other authorities for development programs. Manage preparation, review, and submission of INDs, BLAs/MAAs, CTAs, and related amendments; provide regulatory guidance to multidisciplinary teams; review clinical and nonclinical data and protocols; ensure submission completeness; supervise regulatory submission planning and staff.

Lead regulatory strategy and submissions (IND/CTA/BLA/MAA) for drug development programs. Serve as liaison with FDA and other health authorities, provide regulatory guidance to cross-functional teams, review clinical and preclinical data and protocols, ensure compliance of submissions, and supervise preparation and submission activities.