Regulatory Affairs Manager

University of Florida; Gainesville (FL); On-site; USD 88,000 - 95,000; Full time

Job summary

University of Florida is seeking a Regulatory Affairs Manager on the UF Health Cancer Institute team at the Gainesville campus to lead regulatory compliance for cancer clinical trials. You will oversee IRB submissions, renewals, and documentation, while mentoring regulatory staff and guiding investigators on federal and sponsor requirements.

The role emphasizes collaboration across multidisciplinary clinical research teams, development of SOPs, and ensuring audit readiness, CTMS compliance, and

Qualifications

• Master's degree in appropriate area of specialization; or a bachelor's degree in appropriate areas of specialization and two years of experience.
• Professional clinical research and/or oncology certification (through SOCRA, ACRP, etc.) are required at the earliest of 12 months from hire or eligibility.

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 CTMS compliance.
• Developing and implementing standard operating procedures, workflow improvements, and compliance monitoring strategies to support research excellence and operational efficiency.

Skills

Leadership

Regulatory Affairs

IRB

Team Management

Clinical Research

Communication

Project Management

Education

Master's degree in appropriate area of specialization

Bachelor's degree in appropriate areas of specialization + 2 years experience

SOCRA/ACRP certification

Job description

Regulatory Affairs Manager

Job No: 541646

Work Type: Full Time

Location: Main Campus (Gainesville, FL)

Categories: Grant or Research Administration, Health Care Administration/Support, Legal/Audit Services/Compliance

Department: 27320503 - HA-UFHCI CRO REGULATORY

Job Description

Classification Title: MGR, Clinical Research

Classification Minimum Requirements: 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.

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.

Expected Salary: $87,500 - $95,000

This is a TEAMS position, and is eligible for a suite of excellent benefits, retirement options, and paid leave.

About the City of Gainesville

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!

For more information, check out: The Guide to Greater Gainesville and Explore Gainesville in 60 seconds.

Required Qualifications

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

Professional clinical research and/or oncology certification (through SOCRA, ACRP, etc.) are required at the earliest of 12 months from hire or eligibility.

Preferred

Knowledge/Experience:

• 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).

Qualities:

• 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.

Skills/Abilities:

• 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.

Special Instructions to Applicants

The University of Florida is a member of the State University System of Florida and an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit.

• Cover Letter or Letter of Interest
• Curriculum Vitae or Resume
• List of Three Professional References

This is not a remote work position, and is located on the University of Florida's Main Campus in Gainesville, FL.

Application must be submitted by 11:55 p.m. (ET) of the posting end date.

Health Assessment Required:No

Applications Close: 27 October 2026

Our Commitment

The University of Florida is an Equal Employment Opportunity Employer.

Hiring is contingent on eligibility to work in the U.S. The University of Florida is a public institution and is subject to all requirements under Florida Sunshine and Public Record laws. If an accommodation due to a disability is needed to apply for this position, please call 352-392- 2477 or the Florida Relay System at 800-955-8771 (TDD) or visit Accessibility at UF.