DIRECTOR-REGULATORY AFFAIRS-ARO-CLINICAL TRIALS
The University of Alabama at Birmingham

General Responsibilities:
The Director of ARO-CT Regulatory Affairs provides enterprise-level leadership for regulatory strategy and operations supporting clinical research across UAB. The position establishes and directs a centralized regulatory program to ensure institutional and investigator compliance with all applicable federal, state, and local regulations; Good Clinical Practice (GCP) guidelines; and UAB policies governing human subjects research. The Director leads the development, implementation, and continuous improvement of regulatory policies, standard operating procedures (SOPs), training, and quality systems. The Director serves as the institutional subject-matter expert for FDA-regulated research (IND/IDE and related submissions). The Director partners with investigators, department leadership, the IRB, and compliance offices to mitigate regulatory risk. The Director sets program priorities, allocates resources, defines performance metrics, and ensures timely, accurate filings (e.g., IND/IDE, ClinicalTrials.gov) and readiness for audits/inspections. The Director is responsible for operational planning for the regulatory affairs program, including forecasting staffing/resource needs and supporting development of budgets or fee-for-service models as applicable; may oversee program expenditures and vendor/service costs consistent with institutional policies.

Key Duties & Responsibilities:
1. Provide strategic direction and operational leadership for the ARO-CT regulatory affairs function, including defining scope of services, service-level expectations, and program priorities aligned with institutional research goals.
2. Develop, implement, and govern regulatory policies, SOPs, tools, and guidance to standardize practices across departments and improve quality, efficiency, and compliance for clinical research regulatory activities.
3. Direct and oversee IND/IDE and other FDA-regulated submission activities, including initial submissions, protocol amendments, safety reporting, responses to FDA requests for information, annual reporting, and maintenance of required regulatory files and tracking systems.
4. Serve as the institutional expert and primary consultative resource for investigators and study teams on FDA regulations, ICH-GCP, and other applicable requirements; provide complex problem-solving and risk-based guidance for novel or high-risk trials.
5. Oversee the institutional ClinicalTrials.gov program for applicable clinical trials, including governance, compliance monitoring, quality review, escalation pathways, and reporting of performance metrics to leadership.
6. Establish and maintain a regulatory quality management system, including internal audits/assessments, inspection readiness activities, issue triage, corrective and preventive action (CAPA) oversight, and continuous improvement initiatives.
7. Design and deliver role-based training and competency standards for regulatory personnel and study teams; maintain training content, job aids, and communications related to regulatory changes and institutional expectations.
8. Partner with the IRB, Office of Clinical Research, Compliance/Legal, and other stakeholders to align regulatory processes, resolve escalations, and ensure consistent interpretation and application of regulatory requirements across the institution.
9. Develop and monitor key performance indicators (KPIs) and dashboards (e.g., submission timeliness, CT.gov compliance, audit findings, CAPA closure); use data to drive resourcing decisions and process improvements.
10. Build and lead the ARO-CT regulatory affairs team; hire, train, coach, and evaluate staff; assign and prioritize work; and ensure appropriate coverage and service delivery in support of institutional needs.
11. Perform other duties as assigned.

Salary Pay Range: $104,045 – $169,075

Minimum Requirements:
Bachelor's degree and seven (7) years of related experience required. Work experience may NOT substitute for education requirement. Advanced degree (e.g., Master’s, PhD, etc.) would be preferable.

UAB is an Equal Employment/Equal Educational Opportunity Institution dedicated to providing equal opportunities and equal access to all individuals regardless of race, color, religion, ethnic or national origin, sex (including pregnancy), genetic information, age, disability, and veteran's status. As required by Title IX, UAB prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to UAB's Assistant Vice President and Senior Title IX Coordinator. The Title IX notice of nondiscrimination is located at uab.edu/titleix.