Regulatory Affairs Analyst @ UTHealth Houston

Legal & Compliance (1)

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.

Experience in a clinical research setting, preferably in Regulatory Compliance.

Knowledgeable of current FDA guidance/recommendations and all regulations regarding research protocols.

Ability to write reports and business correspondence.

Possess effective organizational skills, attention to detail, problem solving skills, and the ability to work on multiple tasks.

Must have good time management skills and be able to meet deadlines.

Strong verbal, written and interpersonal communication skills.

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.

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 team meetings, protocol reviews, etc.

Serves as the primary regulatory contact for responding to internal audits.

Performs all other duties as assigned.

Regulatory Affairs Analyst

Mays Cancer Center On-Site

UTHealth Houston