• Provide support to the Compliance Supervisor, assisting in assessing risk and developing compliance work plan initiatives. • Understand, track, and document compliance to the Company's compliance program consistent with the 7 elements of an effective compliance program. • Conduct thorough conflict of interest checks on new employees, client relationships, and other relevant situations. • Assist with reviewing all protocols established for client testing. • Receive, provide guidance, investigate, and respond to organizational integrity and compliance questions and concerns as assigned. • Ensure all employees follow established Code of Conduct guidelines. • Ensure all referring physician certifications and licenses remain up-to-date. • Ensure sanction checks performed for all new hires, vendors, and referring physicians. • Provide any other departmental support as needed.

Location: Remote - TX Department: Research Operations Shift: First Shift (United States of America) Standard Weekly Hours: 40 Summary: The Regulatory Affairs Coordinator I is new to research regulatory affairs with limited or no regulatory affairs knowledge. May have experience in science, clinical studies or engineering and may understand basic aspects of clinical research. This person is responsible for assisting other regulatory affairs employees with specific tasks including filing, binder preparation and maintenance, basic IRB submissions and communications, essential regulatory document development and maintenance, and audit participation. The Regulatory Affairs Coordinator I will grow their knowledge of regulatory guidelines through ongoing training by internal staff. Qualifications: About Us: Cook Children's Health Care System Cook Children's Health Care System offers a unique approach to caring for children because we are one of the country's leading integrated pediatric health care delivery organizations. Patients benefit from the integrated system because it allows Cook Children's to use all of its resources to treat a patient and allows for easy communication between the various companies by physicians with a focus on caring for children and adolescents. Cook Children’s is an equal opportunity employer. As such, Cook Children’s offers equal employment opportunities without regard to race, color, religion, sex, age, national origin, physical or mental disability, pregnancy, protected veteran status , genetic information, or any other protected class in accordance with applicable federal laws. These opportunities include terms, conditions and privileges of employment, including but not limited to hiring, job placement, training, compensation, discipline, advancement and termination.

• Serve as regulatory subject matter expert and member on multidisciplinary project teams (food and companion animal) responsible for developing veterinary pharmaceutical and biopharmaceutical products • Develop and implement the regulatory strategy for assigned teams, accepting the responsibility of all US FDA regulatory submissions and interactions for that project • Serve as liaison with Global Research and other VMRD colleagues to help provide early regulatory input into early phase projects • Liaise with GPM and Therapeutic Area Leads to establish suitable product profiles, regulatory jurisdiction, label claims, product support materials, as well as project progression documentation • Assemble original and supplemental applications and coordinate subsequent responses to US Regulatory Authority questions • Liaise directly with FDA-CVM as needed to achieve objectives • Liaise with EU and CALAR regulatory staff to facilitate global registration activities, where appropriate

• Support the National General (NatGen) SOX audit engagement by supporting audit requests evidence gathering. • Create Audit request management (ARM) request and assignment of requests and following up with control owners. • Organize evidence and upload documentation to External auditors’ collaboration tool. • Maintain the EIRC SOX evidence repository, perform basic data testing in Excel, and document meeting notes. • Participate in business process walkthroughs and capture process changes for SOX technology inventory updates.