Regulatory Affairs Manager

University of Florida•Gainesville, FL

14h•$87,500 - $95,000•Onsite

About The Position

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. In your new role you will be responsible for the following: 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. This is a management level position, ideal for candidates with experience in clinical research regulatory affairs, human subjects research compliance, and team leadership within an academic or healthcare research environment. Employees in these roles operate as part of our collaborative research enterprise and are fundamental to the progress of cancer research being conducted at the University of Florida. A complete job description will be provided to candidates selected for interview.

Requirements

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.
Proficiency with databases and/or patient data
Proficiency with Microsoft Office suite.
Professional clinical research and/or oncology certification (through SOCRA, ACRP, etc.) are required at the earliest of 12 months from hire or eligibility.

Nice To Haves

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 (eg. Managing at UF – The Supervisory Challenge).
Exceptional customer service with a professional, trustworthy, approachable demeanor and strong interpersonal skills, as well as the ability and desire to work with a broad range of people and appreciate a culturally diverse organization.
Highly resourceful team-player with the ability to independently and with limited supervision work toward common goals as part of an administrative team.
Demonstrated integrity, dependability, sound judgment, teamwork and resourcefulness to establish and maintain collaborative, positive and effective working relationships with internal and external partners.
Proven sense of professional ethics and conduct, understanding and effective use of Emotional Intelligence strategies and skills.
Forward-thinking mentality, actively seeking opportunities to learn, seek out, and apply new knowledge, methods, and information and proposing creative solutions with strong decision-making capability.
Collaborative, uplifting, and positive personality.
Ability to work with multigenerational teams.
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.
Proficient time management skills and ability to successfully manage multiple priorities seamlessly with excellent attention to detail.
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 confidentiality.
Demonstrated proficiency in project management, clinical research/trials experience is highly desirable.

Responsibilities

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.