Job Summary:

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.

Job Duties:

• 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 team meetings, protocol reviews, etc.
• Serves as the primary regulatory contact for responding to internal audits.
• Performs all other duties as assigned

Education:

Bachelor's degree is required; an advanced degree in such fields as Public Administration, Public Policy or Law is preferred.

Experience:

Three (3) years of experience in a government relations environment is required. Experience on Capitol Hill or in a related science, technology, or higher education policy position is preferred.