Senior Regulatory Analyst,

With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to U.S. News & World Report, we invest in you with opportunities for career growth and development to align with your future goals.

About the Role

In addition to the responsibilities outlined for a Senior Regulatory Analyst, this position provides strategic oversight and operational leadership for the Institutional Animal Care and Use Committee (IACUC) compliance program. The role focuses on managing and executing the Semiannual Facility Inspection (SAFI) program and supporting Post-Approval Monitoring (PAM) activities. This position serves as a key resource to the research community, offering regulatory guidance, education, and training. The Senior Regulatory Analyst exercises significant autonomy in planning, prioritizing, and leading complex compliance and oversight initiatives, including laboratory and facility site visits, SAFI and PAM activities, and the development, implementation, and maintenance of institutional policies, standard operating procedures (SOPs), and compliance processes.

This role requires strong project management skills to manage concurrent priorities, develop and maintain databases, and track compliance monitoring, inspections, corrective and preventive action plans, and program metrics. The position prepares comprehensive reports and analyses for the IACUC and Institutional Official, manages follow-up activities through resolution, and leads projects to improve efficiency, strengthen compliance oversight, and enhance program effectiveness. Excellent communication, interpersonal skills, sound judgment, adaptability, confidentiality, and a strong customer service orientation are essential.

Responsibilities

• Provide expert-level knowledge (application and interpretation) of federal regulations (DHHS, PHS, FDA, USDA, HIPAA, etc.), state regulations and policies, and institutional policies relevant to human or animal research and privacy for campus-wide research.
• Review complicated scientific research documents and identify substantive ethical and regulatory issues as well as institutional policy issues.
• Approve protocol submissions eligible for expedited/designated member review and document the decision-making process as required by federal regulations in applicable reviewer checklists, databases, and correspondence.
• Provide guidance to research committee staff, board members/chairs, and researchers on resolving complex and controversial issues.
• Solve, recommend, and implement solutions for customer and affiliated inter-institution processes and procedures related to protocol submissions and the regulatory review process.
• Direct, analyze, coordinate, and evaluate research committee operations and procedures. Capture and document controverted ethical and scientific issues identified during the review process in the minutes, summarizing judgments/resolutions for each item of review.
• Stay current on changes to regulations by reading literature and attending training, considering implications for institutional review processes.
• Provide education and training to faculty, study staff, HRPP/IACUC Office staff, and Board members related to the protocol review process. Develop and distribute resource materials to improve protections for research subjects.
• Prepare, send, and track incident notifications to researchers, institutional leadership, and federal officials as required by federal regulations (e.g., FDA, USDA, HHS, PHS, DOD, DOE).
• Respond to follow-up inquiries by federal agencies, faculty, and officials from affiliated institutions regarding notifications from the research committee.
• Develop, cultivate, and maintain working relationships with internal/external departments/agencies and other organizations associated with and/or receiving benefit from the research program.
• Establish research committee goals and objectives, direct research committee evaluation and quality control activities, and develop and/or approve schedules, priorities, and standards for achieving goals.
• Design, execute, and ensure the effectiveness of a system of internal controls, providing reasonable assurance that operations are effective and efficient.
• Perform other duties as assigned.

Requirements

• Bachelor's Degree in a related field.
• 5 years of related research experience with a Bachelor's degree, or 3 years of related research experience with a Master's degree.

Preferred Qualifications

• Master's Degree or advanced science degree.
• Previous service on an Institutional Review Board or Institutional Animal Care and Use Committee (IACUC).
• Certification as a Certified Professional in IACUC Administration (CPIA) or Certified IRB Professional (CIP), or extensive current knowledge of regulations governing human or animal research protections.

Skills

• Demonstrated experience coordinating or leading compliance oversight activities, including facility inspections, site visits, audits, or monitoring programs.
• Strong project management skills with the ability to independently lead multiple complex projects and priorities simultaneously.
• Experience developing, implementing, and maintaining policies, SOPs, compliance processes, and corrective action plans.
• Proven ability to analyze data, monitor trends, develop metrics, and maintain compliance tracking systems and databases.
• Excellent written and verbal communication skills.
• Strong presentation, training, and educational outreach skills.
• Ability to exercise sound judgment, critical thinking, and problem-solving in complex situations.
• Strong organizational skills with exceptional attention to detail and follow-through.
• Demonstrated ability to build collaborative relationships.
• Commitment to customer service, professionalism, confidentiality, and continuous process improvement.
• Proficiency with Microsoft Office applications, databases, and document management systems such as SharePoint.

Benefits

• PPO medical plan, available day one at no cost for full-time employee-only coverage.
• 100% coverage for preventive healthcare with no copay.
• Paid Time Off, available day one.
• Retirement Programs through the Teacher Retirement System of Texas (TRS).
• Paid Parental Leave Benefit.
• Wellness programs.
• Tuition Reimbursement.
• Public Service Loan Forgiveness (PSLF) Qualified Employer.
• On-site childcare.
• Wage and merit increases.

Primary work location: Texas-Dallas-5323 Harry Hines Blvd. Full-time, day shift.