University of California San Diego
Manager, Regulatory Affairs - Hybrid - 134458
University of California San Diego, San Diego, California, United States, 92189
#134458 Manager, Regulatory Affairs - Hybrid
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.
DESCRIPTION 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 that brings together UC San Diego, San Diego State University, and the La Jolla Institute of Immunology to advance cancer research and care.
Reporting directly to the Executive Administrative Director of the Moores Cancer Center Clinical Trials Office (CTO), the Manager, Regulatory Affairs leads a team of Regulatory Coordinators and takes on key programmatic responsibilities to strengthen regulatory practices across the clinical research organization.
The incumbent demonstrates expertise in regulatory matters, serves as a subject matter expert when engaging with sponsors and auditors, and designs large‑scope, high‑complexity research projects that drive the MCC CTO’s overall success.
Managing a team of highly skilled professionals in a matrixed organization, the Regulatory Manager ensures the achievement of the MCC CTO’s activation targets and ongoing compliance with regulatory requirements for all active clinical trials under the CTO’s purview.
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.
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 effectively manage multiple priorities and meet the demands of a fast‑paced and dynamic work environment.
Demonstrated experience managing people with a wide range of educational backgrounds and skills; demonstrated management and conflict resolution skills to effectively lead and motivate others.
Strong communicator; includes verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills.
Excellent interpersonal skills, including problem‑solving, teamwork development, leadership, mentorship, and ability to cultivate relationships with multiple stakeholders at various levels of administration.
Proficiency with word processing, spreadsheet software, clinical trial management systems, and clinical information and documentation application programs.
Collaboration skills to interface and coordinate with cross‑functional teams and influence and persuade in program integration.
PREFERRED QUALIFICATIONS
Advanced degree.
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.
EQUAL OPPORTUNITY EMPLOYER STATEMENT The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law.
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This position will work a hybrid schedule which includes a combination of working both onsite at Moores Cancer Center and remote.
DESCRIPTION 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 that brings together UC San Diego, San Diego State University, and the La Jolla Institute of Immunology to advance cancer research and care.
Reporting directly to the Executive Administrative Director of the Moores Cancer Center Clinical Trials Office (CTO), the Manager, Regulatory Affairs leads a team of Regulatory Coordinators and takes on key programmatic responsibilities to strengthen regulatory practices across the clinical research organization.
The incumbent demonstrates expertise in regulatory matters, serves as a subject matter expert when engaging with sponsors and auditors, and designs large‑scope, high‑complexity research projects that drive the MCC CTO’s overall success.
Managing a team of highly skilled professionals in a matrixed organization, the Regulatory Manager ensures the achievement of the MCC CTO’s activation targets and ongoing compliance with regulatory requirements for all active clinical trials under the CTO’s purview.
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.
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 effectively manage multiple priorities and meet the demands of a fast‑paced and dynamic work environment.
Demonstrated experience managing people with a wide range of educational backgrounds and skills; demonstrated management and conflict resolution skills to effectively lead and motivate others.
Strong communicator; includes verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills.
Excellent interpersonal skills, including problem‑solving, teamwork development, leadership, mentorship, and ability to cultivate relationships with multiple stakeholders at various levels of administration.
Proficiency with word processing, spreadsheet software, clinical trial management systems, and clinical information and documentation application programs.
Collaboration skills to interface and coordinate with cross‑functional teams and influence and persuade in program integration.
PREFERRED QUALIFICATIONS
Advanced degree.
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.
EQUAL OPPORTUNITY EMPLOYER STATEMENT The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law.
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