Regulatory Affairs Manager (Hybrid)

Job description

About the Position: The Regulatory Affairs Manager will oversee assigned regulatory team staff, navigate submission/approval pathways, lead the development of new protocol submissions and essential research documents, oversee and submit regulatory lifecycle actions, develop and maintain recordkeeping systems and procedures, advise study staff on good research practices, provide monitoring support, and ensure research lifecycle compliance of all assigned projects. Experience with FDA-regulated clinical trials highly desired. Previous experience in research conduct preferred. ***PLEASE NOTE: This is a partially-remote position. Must live within a commutable distance of the Bethesda, MD area for reporting to site two days per week. A thorough government background check will be required. About the Program: The Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR) Program was established to support the execution of clinically relevant research to advance the care of service members with non-combat related musculoskeletal injury (MSI). Headquartered at the Uniformed Services University of the Health Sciences (USU) in Bethesda, MD, MIRROR provides coordination...