2 regulatory affairs specialist jobs found in Aurora

Regulatory Strategist Manager Regulatory Strategist Manager - 39571 University Staff Description University of Colorado Anschutz Medical Campus Department: OVCR Investigational New Drug/ Device Office Job Title: Regulatory Strategist Manager Position #:00846482 - Requisition #: 39571 Job Summary: Reporting to the Program Director of the IND/IDE Office in the Office of the Vice Chancellor for Research (OVCR), the IND/IDE Office Regulatory Strategist is a high impact and high visibility role, responsible for developing strategy, engaging external consultants and regulatory support for studies at CU Anschutz that are supported by the IND/IDE Office. This role will work closely with other leaders in the OVCR, Cancer Center, Gates Institute, and CHCO to support CU held INDs and CU investigator-held INDs. The mission of this group is to partner with CU Anschutz investigators and stakeholders to develop innovative therapies and facilitate the...

Regulatory Affairs Coordinator (Open Rank: Senior Principal) Regulatory Affairs Coordinator (Open Rank: Senior - Principal) - 39468 University Staff Description University of Colorado Anschutz Medical Campus Department: Ophthalmology Job Title: Regulatory Affairs Coordinator (Open Rank: Senior - Principal) Position # 00846414 - Requisition # 39468 Job Summary: The Department of Ophthalmology has an immediate opening for a full-time Research Services Senior-Principal Professional (open rank)-Regulatory Affairs Coordinator. The position will independently maintain and manage all IRB and regulatory processes for department research studies. Primary duties will include, but not be limited to: submissions to the Institutional Review Board (IRB) of record including amendments, unanticipated problems, continuing reviews, and study closures; maintenance of the investigator site file/regulatory binder and all essential documents including...