Regulatory Affairs Analyst (Mays Cancer Center)

Job description

Under general supervision, responsible for assisting with obtaining government approval for new products that are covered by government regulations, including the preparation of marketing applications. Education: Bachelor's Degree degree is required; an advanced degree in such fields as Public Administration, Public Policy or Law is preferred. - Prepares and submits new studies and amendments to the appropriate regulatory agencies within and outside the institution in a timely manner. - Collaborates between the Principal Investigators (PI), research staff and the Institutional Review Board (IRB) regarding protocol reviews, approvals, and amendments. - Obtains documents from all involved entities and ensures that information flow is complete and timely. - Provides periodic status reports to the principal investigator and research staff as required. - Processes new studies for internal review and serves as the contact for completion and collection of the regulatory affairs questionnaire for Sponsors/Contract Research Organizations (CRO). - Processes Investigational New Drug (IND )Safety Reports, attends internal meetings such as exit meetings for study monitors and auditors, disease...