Regulatory Affairs Manager

Job Details

Job No: 538803

Work Type: Full Time

Location: Main Campus (Gainesville, FL)

Categories: Executive/Director/Management, Allied Health, Grant or Research Administration, Health Care Administration/Support, Legal/Audit Services/Compliance

Department:  - HA-UFHCI CRO REGULATORY

MGR, Clinical Research

Master's degree in appropriate area of specialization; or a bachelor's degree in appropriate areas of specialization and two years of experience.

The UF Health Cancer Institute is the 72nd NCI designated cancer center and the only one at a public university in the State of Florida. As a matrix cancer center, we span all of the University of Florida's 16 colleges, pulling together a world‑class, multi‑disciplinary membership of over 350 faculty and 150 staff to address the challenges of the cancer burden faced by the population we serve as we work together to find a cure.

As a Regulatory Affairs Manager at the UF Health Cancer Institute (UFHCI), you will be responsible for leading regulatory compliance operations within the Clinical Research Office, overseeing Institutional Review Board (IRB) regulatory processes, and supervising a team supporting cancer clinical trials. Strong leadership, regulatory expertise, and the ability to collaborate across multidisciplinary clinical research teams are necessary for success in this role.

• Overseeing regulatory operations for clinical trial protocols, including IRB submissions, approvals, renewals, amendments, and regulatory documentation tracking.
• Leading, mentoring and managing regulatory staff, including IRB Specialists and Assistants, while supporting staff development, training, and performance management.
• Providing regulatory guidance to investigators, research teams, and institutional partners to ensure compliance with federal regulations, sponsor requirements, and institutional policies.
• Directing portfolio oversight and quality assurance activities, including audit readiness, regulatory reporting, and clinical trial management system (CTMS) compliance.
• Developing and implementing standard operating procedures, workflow improvements, and compliance monitoring strategies to support research excellence and operational efficiency.

$87,500 - $95,000

Home to the University of Florida, one of the nation's top public universities, Gainesville offers vibrant academic and healthcare communities alongside an affordable cost of living, no state income tax, and mild winters. Enjoy the outdoors with over 30 miles of bike trails, freshwater springs, and numerous water activities, plus easy access to beaches and world‑class theme parks.

Gainesville combines historic charm with modern amenities, including a great school system, a lively downtown, and farmers' markets and craft breweries. Discover professional growth and quality of life in Gainesville—where community, innovation, and work‑life balance meet!

• Bachelor's degree in Health Care, Public Health, or a related field.
• Regulatory or clinical trials coordination experience in an Academic Medical Center.
• Comprehensive and demonstrated understanding of Good Clinical Practice.

• Master's Degree in Regulatory Affairs, Health Care, Public Health, or a related field.
• Ten or more years of research experience and/or training in an Academic Medical Center.
• Prior experience as a supervisor or team lead and/or completion of leadership/management training program (e.g., Managing at UF - The Supervisory Challenge).

• Proficiency with databases and/or patient data.
• Proficiency with Microsoft Office suite.
• Expertise in NCTN/ECTCN Cooperative group trials.
• Proficient time management skills and ability to successfully manage multiple priorities.
• Demonstrated ability to achieve high performance goals and meet deadlines in a fast‑paced environment.
• Excellent meeting coordination skills, delegation, and attention to detail.
• Exceptional interpersonal skills - in person, online and by phone, always maintaining a high level of professionalism and commitment to…