Supervisor Regulatory Affairs

Work Shift : Please see job description for details.

Time Type : Full time

Department : CC035772 Regulatory Clinical Research Operations

Summary : The Supervisor, Regulatory Affairs will oversee the development and implementation of policies and procedures to ensure compliance with local and federal regulations. This role will manage a team of regulatory professionals and work closely with investigators, sponsors, and institutional review boards (IRBs) to facilitate regulatory submissions and approvals.

Responsibilities :

• Lead, supervise, and mentor a team of regulatory coordinators, providing strategic direction, performance feedback, and professional development opportunities. Serve as the regulatory team lead and subject matter expert for ACRI.
• Oversee the end-to-end process for the preparation, submission, and maintenance of regulatory documents, including IRB and FDA filings (sIND, IND, IDE).
• Ensure all clinical research projects are executed in compliance with applicable regulatory requirements (FDA, ICH-GCP, HIPAA, etc.) and internal policies
• Act as the primary regulatory liaison between the research team and external / internal stakeholders, including sponsors, IRBs, regulatory agencies, and oversight bodies.
• Lead the development and execution of regulatory strategies, systems, SOPs, and best practices to optimize regulatory operations and ensure audit readiness.
• Track and interpret changes in regulatory requirements, proactively guiding the team and research staff on compliance expectations.
• Build strong cross-functional partnerships across Clinical Operations, Research Integrity, and Corporate Compliance, ensuring alignment with broader organizational goals.
• Represent the organization in interactions with regulatory bodies, including the UAMS IRB and the UAMS Office of Research Regulatory Affairs.
• Serve as the process owner and subject matter expert for the eReg electronic regulatory management system, ensuring efficient and compliant document workflows.
• Establish team goals, performance metrics, and continuous improvement plans to drive operational excellence in regulatory affairs.
• Other duties as assigned

Requirements :

Arkansas Children's is the only hospital system in the state dedicated to caring for children, which enables us to uniquely shape the landscape of pediatric care in Arkansas. Arkansas Children's is driven by four core values—safety, teamwork, compassion and excellence—which inform every action.

Arkansas Children's provides equal employment opportunity to all persons without regard to age, race, color, religion, national origin or citizenship status, disability, military status, sexual orientation, gender identity or expression, pregnancy or any other category protected by federal, state and local laws. Further, Arkansas Children's will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

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