Michael Halloran has over a decade of academic and industry experience in pharma, research, teaching, and consulting. Michael provides in-house technical and medical writing and manages the submission of regulatory, quality, and clinical deliverables. Additionally, Michael provides on-demand support for regulatory strategy projects, inspection readiness programs, and process improvement and harmonization endeavors.
Before joining Halloran, Michael spent more than five years working at Regeneron Pharmaceuticals within the Biology Group of the Quality Control Department. His area of expertise at that time was in establishing and maintaining laboratory compliance with applicable regulations and leading inspection readiness and remediation efforts. His position concentrated on performance and validation of Real-time Quantitative PCR methods for DNA analysis, ELISA techniques, and cell-based potency assays. His duties also included collaborating with cross-functional teams for CMC investigations and technology transfer.