Supervisor Regulatory Affairs

Supervisor, Regulatory Affairs

Arkansas Children's is a tobacco free workplace. Flu vaccines are required. Arkansas Children's is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, protected veteran status or any other characteristic protected by federal, state, or local laws.

This position has been designated as safety sensitive and cannot be filled by a candidate who is a current user of medical marijuana.

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 to facilitate regulatory submissions and approvals.

Additional Information :

Required Education :

Bachelors Degree or Equivalent Experience

Required Work Experience :

Related Field - 5 years of experience

Required Certifications :

Recommended Certifications :

Certified Clinical Research Coordinator (CCRC) - Association of Clinical Research Professionals, Certified Clinical Research Professional (CCRP) - Society of Clinical Research Associates

Description :

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.

Ensure all clinical research projects are executed in compliance with applicable regulatory requirements 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