UC San Diego Health · 1 month ago
Manager, Regulatory Affairs - Hybrid - 134458
San Diego, CA
Full-time
Hybrid
Senior Level
$94K/yr - $164K/yr
5+ years expUC San Diego Health is a leading medical institution dedicated to transforming cancer care. The Manager of Regulatory Affairs will lead a team to enhance regulatory practices, manage clinical trials, and ensure compliance with regulatory requirements.
Health Care
Responsibilities
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
Qualification
Required
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, prioritize projects and meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities
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. Demonstrated experience in training others in the field of research
Demonstrates good problem-solving and analytical skills. Creatively addresses complex or new problems
Strong communicator; includes verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Clear and concise communicator. Ability to influence and negotiate
Excellent interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership, mentorship. Interpersonal skills to effectively motivate others. Works well with others to achieve common goals. Ability to cultivate relationships with multiple stakeholders at various levels of administration
Ability to perform all commonly applicable functions in word processing and spreadsheet software. Effectively uses campus' clinical information and documentation application programs. Proven ability utilizing clinical trial management systems
Skills to work collaboratively with other cross-functional teams. Ability to interface and collaborate with other members of an extended study team. Ability to influence / persuade. Proven ability to effectively coordinate and integrate programs with others in division, department, and organization
Preferred
Advanced degree
Company
UC San Diego Health
UC San Diego Health is the only academic health system in the San Diego region.
10001+ employees
Funding
Current Stage
Late StageTotal Funding
$0.2MKey Investors
The Beryl InstituteThe Conrad Prebys Foundation
2025-10-31Grant
2023-06-26Grant· $0.2M
Leadership Team
Christian Dameff
Medical Director of Cybersecurity
Sandip Patel
Professor
Recent News
2025-11-08
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