Regulatory Affairs Analyst (Neurology)

Job Description

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.

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.

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.

Additional Information