Regulatory Affairs Analyst ( Neurology )
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.
Additional Licenses and Certifications:
None.
Supervisory Requirements:
None
UT Health San Antonio is an equal employment opportunity employer. All qualified applicants will receive equal consideration for employment in accordance with applicable federal laws, state statutes, and University policies.
If you need a reasonable accommodation, please email careers@uthscsa.edu.
