Teams at KMR Search Group

Lead global CMC regulatory strategy and preparation of eCTD submissions for investigational and commercial biologics. Provide regulatory guidance to project teams, interact with health authorities, monitor evolving CMC regulations, and manage a team of Regulatory Affairs directors and managers.

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.

Lead facility engineering, construction project management, HSE and environmental compliance across pharmaceutical sites. Ensure GMP metrology, maintenance harmonization, emergency response, permitting, budgets, performance metrics, and staff development to maintain compliant, safe cleanroom and warehouse operations.