Senior Regulatory Affairs Associate

Summary

The Senior Regulatory Affairs Associate works to support the Protocol Office and investigators associated with The Texas Children's Cancer and Hematology Centers (TXCH). As a Senior Regulatory Affairs Associate in Regulatory Affairs, multi-faceted, complex pediatric oncology treatment protocols will be assigned. The role is expected to interface with other academic centers, NIH funded consortia, the National Cancer Institute, the Federal Drug Administration (FDA), and industry sponsors on highly sensitive and confidential projects. This position supports all aspects of regulatory compliance for a specified portfolio of clinical trials. This support includes, but is not limited to, reviewing protocols and protocol related documents, submitting protocols to regulatory agencies and review committees and ensuring successful navigation of approval processes for clinical research. This position requires expertise and understanding of clinical research and applicable regulations.

This position will be assigned the more complex BMT and cellular therapy studies within the Pediatric Hematology and Oncology Center at BCM.

This position requires onsite work and does not offer 100% remote work option.

Job Duties

• Applies a detailed understanding of federal and international regulatory requirement when preparing regulatory review applications.
• Assists and advises Investigators on their compliance with federal and international regulation acquirements, obligations and responsibilities that govern the conduct of clinical research studies.
• Assigned studies in pediatric oncology and hematology human subjects research with an emphasis on IND trials.
• Coordinates regulatory correspondence across internal stakeholders and external institutions. Prepares protocol documents and required regulatory forms in order to obtain institutional and regulatory agency approval for the conduct of clinical research projects at the TXCH.
• Assists with training junior staff under the guidance of the Director of Regulatory Affairs.

Minimum Qualifications

• Bachelor's degree.
• Four years of relevant experience.

Preferred Qualifications

• Four or more years of experience in regulatory affairs for clinical research at an academic medical center or hospital with knowledge of clinical research practices and regulations.
• Regulatory Affairs Certification

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

5632

CA; CH