Teams at KMR Search Group

Lead global regulatory and quality assurance strategy for a clinical-stage pharmaceutical company. Oversee FDA and international submissions, manage QA systems (SOPs, CAPA, document control, training), advise senior leadership on regulatory risk, and direct cross‑functional regulatory and quality activities to ensure compliance and timely approvals.

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.