Jobs 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.

Lead regulatory strategy and submissions (primarily CMC, also clinical and non-clinical) for investigational and marketed products. Serve as RA lead on cross-functional teams, liaise with FDA and other health authorities, drive regulatory due diligence, and implement policies to ensure timely approvals and compliance with ICH, FDA, and EU guidelines.

Lead global clinical regulatory activities including strategy and operations for IND/CTA and BLA submissions, liaison with FDA and other health authorities, and support clinical and marketing objectives to ensure compliance and timely approvals.

Provide global pharmacovigilance and safety leadership for immunology/inflammation products, including signal detection, risk/benefit assessment, safety strategy, regulatory submissions, cross-functional team leadership, and preparation of periodic safety reports and labeling input.