Manager, Regulatory Affairs - Hybrid

Manager, Regulatory Affairs - Hybrid - 134458

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Payroll Title CLIN RSCH SUPV 2

Department CANCER CENTER/Clinical Trials Office

Hiring Pay Scale $94,400 - $164,000 / Year

Worksite Moores Cancer Center

Appointment Type Career

Appointment Percent 100%

Union Uncovered

Total Openings 2

Work Schedule Days, 8 hrs/day, Monday-Friday

#134458 Manager, Regulatory Affairs - Hybrid

Extended Deadline:
Mon 12/29/2025

Apply Now

UC San Diego values and welcomes people from all backgrounds. If you are interested in being part of our team, possess the needed licensure and certifications, and feel that you have most of the qualifications and/or transferable skills for a job opening, we strongly encourage you to apply.

This position will remain open until a successful candidate has been identified.

Special Selection Applicants:
Apply by 03/12/2025. Eligible Special Selection clients should contact their Disability Counselor for assistance.

This position will work a hybrid schedule which includes a combination of working both onsite at Moores Cancer Center and remote.

The Moores Cancer Center (MCC) is one of just 53 NCI-designated Comprehensive Cancer Centers in the United States and the only one in San Diego County. As a consortium cancer center, it is a collaborative partnership between the UCSD: encompassing 28 departments, 6 schools (School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, School of Public Health, Jacobs School of Engineering, School of Biological Sciences & the School of Physical Sciences), UCSD Health oncology hospitals and clinics;

the basic and public health research and outreach of San Diego State University (SDSU), and the basic and translational research of the La Jolla Institute of Immunology (LJI). These various programs and units are all dedicated to fulfilling the Moores Cancer Center's mission of reducing cancer's burden.

Reporting directly to the Executive Administrative Director (EAD) of the Moores Cancer Center Clinical Trials Office (CTO), the Manager, Regulatory Affairs leads a team of Regulatory Coordinators while taking on more programmatic responsibilities. With a focus on program enhancement, the Regulatory Manager collaborates closely with training and education specialists to strengthen key regulatory practices for Regulatory Coordinators, Clinical Research Coordinators and Data Coordinators.

This involves creating and maintaining standard operating procedures, written instructions, and templates to streamline and optimize regulatory processes. Acting as a crucial link between the MCC CTO and various stakeholders, the Regulatory Manager serves as a liaison with both the Institutional Review Board (local and commercial) and ancillary committees.

The incumbent demonstrates expertise in regulatory matters, serving as a subject matter expert when engaging with sponsors and auditors. The scope of the incumbent's responsibilities extends to designing research projects of significant scale and complexity. Their extensive knowledge of clinical research protocols and processes enables them to lead these ambitious projects, contributing to the MCC CTO's overall success.

Lead the CTO Regulatory Affairs unit to support compliant study activation and management of active clinical trials managed by the CTO. Apply extensive knowledge of clinical research protocols and processes to design research projects of large scope and high degrees of complexity. Provide direction on programmatic efforts and developing systems to streamline regulatory processes in a compliant manner. Function as a lead in development of new processes and policies with project team for highly complex clinical trials, along with other UCSD teams / departments.

Monitor, evaluate and coordinate data from multiple systems to recommend new actions / procedures from research analysis. Assess policies and processes to ensure the proposed project plan is compliant with applicable guidelines. Ensure reporting is consistent with external guidelines, university policies and regulations. Develop and inform regulatory personnel about research policies. Perform regulatory checks and develop checklists to confirm compliant clinical trial activation, and provide ongoing guidance to team members to streamline clinical trial activation processes in the realm of regulatory affairs.

Knowledgeable and has experience working with e-Regulatory systems.

Minimum Qualifications

• Nine years of related experience, education/training, OR a Bachelor’s degree in related area plus five years of related experience/training.
• Clinical Trial Professional certification from a professional society within one year in position.
• Broad knowledge of clinical or laboratory research and clinical research philosophy. Demonstrated ability to translate clinical research philosophy into business best practices in a trial setting.
• Demonstrated project management skills. Ability to…