Regulatory Affairs Specialist
Current-Prepares US regulatory submissions to the U.S. Food and Drug Administration (FDA) on behalf of Center for Cancer Research (CCR) for the development of investigational drugs and products. -Prepares eCTD submissions for CCR’s portfolio of >150 Investigational Applications utilizing SharePoint, Veeva RIM, and Extedo eCTD Manager platforms, averaging >50 monthly US submissions including safety reports, new protocols and protocol amendments, investigator brochures, annual reports, FDA responses, CMC amendments, and initial INDs. -Ensures compliance with applicable requirements in the Code of Federal Regulations (CFRs), guidelines developed by the International Council for Harmonization (ICH) and the FDA, and TRI work instructions.-Responsible for tracking, maintaining, and updating regulatory information database, ensuring data quality, and archiving documents-Prepares contact reports, attends client meetings, and develops project specific Standard Operating Procedures in accordance with TRI corporate SOPs and regulatory body specifications.-Coordinates correspondence between the sponsor and its partners including trial sites, clinical investigators, contractors, and product manufacturers-Collaborates with CCR product support team to develop study product preparation forms, resolve temperature excursion events, and support site initiation & continued clinical operations
