UC San Diego
Manager, Regulatory Affairs - Hybrid - 134458
UC San Diego, San Diego, California, United States, 92189
Overview
3855 Health Sciences Dr, La Jolla, CA, 92037 Manager, Regulatory Affairs - Hybrid Extended Review Date: Fri 9/19/2025 This position will remain open until a successful candidate has been identified. This position will work a hybrid schedule which includes a combination of working both onsite at Moores Cancer Center and remote. UC San Diego values equity, diversity, and inclusion. 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.
About MCC CTO 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 UCSD, encompassing 28 departments, 6 schools, 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 programs and units fulfill the MCC CTO mission of reducing cancer burden and advancing science, care, and community engagement.
Responsibilities 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. Responsibilities include:
Lead the CTO Regulatory Affairs unit to support compliant study activation and management of active clinical trials managed by the CTO.
Design research projects of large scope and high complexity; provide direction on programmatic efforts and developing systems to streamline regulatory processes in a compliant manner.
Develop new processes and policies with project teams for highly complex clinical trials; coordinate with UCSD teams and departments.
Monitor, evaluate and coordinate data from multiple systems to recommend new actions/procedures from research analysis.
Ensure reporting is compliant with external guidelines, university policies, and regulations.
Develop and inform regulatory personnel about research policies; perform regulatory checks and develop checklists for compliant trial activation.
Lead ongoing guidance to team members to streamline regulatory affairs processes; ensure activation and ongoing compliance for trials under CTO.
Collaborate with sponsors, auditors, and stakeholders; serve as a subject matter expert in regulatory matters.
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; ability to translate philosophy into business best practices.
Demonstrated project management skills; ability to manage multiple priorities in a fast-paced environment.
Experience managing people with diverse backgrounds; demonstrated training abilities.
Strong problem solving, analytical, and communication skills; ability to influence and negotiate.
Excellent interpersonal skills and ability to collaborate with stakeholders at various levels.
Proficiency in word processing, spreadsheets, and Clinical Trial Management Systems.
Ability to work collaboratively with cross-functional teams and integrate programs with others in the division and organization.
Preferred Qualifications
Advanced degree.
Special Conditions
Employment is subject to a criminal background check.
Pay Transparency Act
Annual Full Pay Range: $97,200 - $182,000 (will be prorated if the appointment percentage is less than 100%)
Hourly Equivalent: $46.55 - $87.16
Factors in determining compensation include experience, skills, knowledge, and other institutional needs. The Hiring Pay Scale is the budgeted range UC San Diego reasonably expects to pay for this position; the Annual Full Pay Range may be broader due to internal equity, budget, and collective bargaining (when applicable).
Apply Now
Safety and policy information
If employed by the University of California, you will be required to comply with the Policy on Vaccination Programs. Federal, state, or local health directives may impose additional requirements. Some certifications (e.g., BLS, NRP, ACLS) require hands-on practice and in-person assessment; online-only certification is not acceptable. UC San Diego Health Sciences includes multiple schools and programs and is committed to a diverse and inclusive environment. Applications should be submitted for current openings only. UC San Diego is an Equal Opportunity Employer. See policy for Anti-Discrimination and information about a smoke-free and drug-free environment.
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3855 Health Sciences Dr, La Jolla, CA, 92037 Manager, Regulatory Affairs - Hybrid Extended Review Date: Fri 9/19/2025 This position will remain open until a successful candidate has been identified. This position will work a hybrid schedule which includes a combination of working both onsite at Moores Cancer Center and remote. UC San Diego values equity, diversity, and inclusion. 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.
About MCC CTO 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 UCSD, encompassing 28 departments, 6 schools, 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 programs and units fulfill the MCC CTO mission of reducing cancer burden and advancing science, care, and community engagement.
Responsibilities 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. Responsibilities include:
Lead the CTO Regulatory Affairs unit to support compliant study activation and management of active clinical trials managed by the CTO.
Design research projects of large scope and high complexity; provide direction on programmatic efforts and developing systems to streamline regulatory processes in a compliant manner.
Develop new processes and policies with project teams for highly complex clinical trials; coordinate with UCSD teams and departments.
Monitor, evaluate and coordinate data from multiple systems to recommend new actions/procedures from research analysis.
Ensure reporting is compliant with external guidelines, university policies, and regulations.
Develop and inform regulatory personnel about research policies; perform regulatory checks and develop checklists for compliant trial activation.
Lead ongoing guidance to team members to streamline regulatory affairs processes; ensure activation and ongoing compliance for trials under CTO.
Collaborate with sponsors, auditors, and stakeholders; serve as a subject matter expert in regulatory matters.
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; ability to translate philosophy into business best practices.
Demonstrated project management skills; ability to manage multiple priorities in a fast-paced environment.
Experience managing people with diverse backgrounds; demonstrated training abilities.
Strong problem solving, analytical, and communication skills; ability to influence and negotiate.
Excellent interpersonal skills and ability to collaborate with stakeholders at various levels.
Proficiency in word processing, spreadsheets, and Clinical Trial Management Systems.
Ability to work collaboratively with cross-functional teams and integrate programs with others in the division and organization.
Preferred Qualifications
Advanced degree.
Special Conditions
Employment is subject to a criminal background check.
Pay Transparency Act
Annual Full Pay Range: $97,200 - $182,000 (will be prorated if the appointment percentage is less than 100%)
Hourly Equivalent: $46.55 - $87.16
Factors in determining compensation include experience, skills, knowledge, and other institutional needs. The Hiring Pay Scale is the budgeted range UC San Diego reasonably expects to pay for this position; the Annual Full Pay Range may be broader due to internal equity, budget, and collective bargaining (when applicable).
Apply Now
Safety and policy information
If employed by the University of California, you will be required to comply with the Policy on Vaccination Programs. Federal, state, or local health directives may impose additional requirements. Some certifications (e.g., BLS, NRP, ACLS) require hands-on practice and in-person assessment; online-only certification is not acceptable. UC San Diego Health Sciences includes multiple schools and programs and is committed to a diverse and inclusive environment. Applications should be submitted for current openings only. UC San Diego is an Equal Opportunity Employer. See policy for Anti-Discrimination and information about a smoke-free and drug-free environment.
#J-18808-Ljbffr