Jobs at KMR Search Group

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.