Paul Dawidczyk
QMS at 4:00 pm – 5:00 pmĀ Paul Dawidczyk is an experienced Regulatory Affairs Professional with knowledge regarding drugs, biologics, and medical devices. Accomplishments include the regulatory strategy, project management, composition and successful submission of multiple regulatory filings, the technical writing of the CMC sections, as well as planning and leading formal meetings concerning these submissions with applicable regulatory agencies. Exceptional knowledge of manufacturing, process development, quality control, and assay development. Possess a strong technical background including proteins, monoclonal antibodies, drug analytes, oligonucleotides, IVDs and medical devices.