Manager, Regulatory Affairs

Title: Manager, Regulatory Affairs

Location: Fountain Valley / Hybrid

Department: Research Administration

Status: Full Time

Shift: Exempt

Pay Range*: $115,169.60 - $172,723.20/annually

MemorialCare is a nonprofit integrated health system that includes four leading hospitals, award-winning medical groups – consisting of over 200 sites of care, and more than 2,000 physicians throughout Orange and Los Angeles Counties. We are committed to increasing access to patient-centric, affordable, and high-quality healthcare; your personal contributions are integral to MemorialCare's recognition as a market leader and innovator in value-based and other care models.

Across our family of medical centers, we support each one of our bright, talented employees in reaching the highest levels of professional development, contribution, collaboration, and accountability. Whatever your role and whatever expertise you bring, we are dedicated to helping you achieve your full potential in an environment of respect, innovation, and teamwork.

Position Summary

The role of Manager of Regulatory Affairs involves overseeing daily clinical research regulatory operations, ensuring compliance with institutional policies, federal regulations, and good clinical practices. Key responsibilities include managing study start-up and approval processes, ensuring studies are FDA inspection-ready, and supervising regulatory affairs coordinators. The manager will maintain team metrics, design systems for workflow efficiency, and stay updated on regulatory changes. Additional duties include developing SOPs, training the regulatory team, preparing for audits, and collaborating with leaders to improve processes. The position also requires working closely with clinical operations to address regulatory non-compliance and implement corrective actions.

Essential Functions and Responsibilities of the Job

• Manage the day-to-day clinical research regulatory operations ensuring responsibilities are completed in accordance with institutional policy, federal regulations and good clinical practices.
• Responsible for hiring, terminating, disciplinary actions and conducting performance reviews.
• Manages the study start-up and approval process from feasibility review to SIV, ensures efficiency and maintenance of regulatory compliance.
• Ensures ongoing research studies are compliant with regulations and all regulatory files are FDA inspection ready.
• Maintain regulatory team metrics and provide insight on portfolio performance indicators, which may include start up activity, deviations, and any reportable findings.
• Supervise the day-to-day activities of the regulatory affairs coordinators.
• Designs, implements, and manages a system for organizing, planning work-flow related to all research. regulatory study activities including developing organizational forms and tools to facilitate study completion and compliance.
• Is up to date on current federal, state, and local regulations and communicates changes to study team.
• Assists in the development, writing, and maintenance of SOPs including work instructions, forms, and templates.
• Responsible for training and development of the research regulatory team as well as the hiring, coaching, counseling, oversight and, performance reviews, termination, and the overall management of the regulatory processes to support day-to-day activities.
• Interact daily with team to ensure overall regulatory compliance.
• Works closely with institutional leaders to create processes for improvement and efficiency.
• Manages sponsor audit and FDA inspection preparation activities.
• In collaboration with the clinical operations manager, work with monitors in order to be able to identify trends in regulatory non-compliance.
• Works with clinical operations manager to develop appropriate corrective action plans and ensure adherence by study teams.
• Registers & maintains clinical trials on clinicaltrials.gov website for applicable studies.
• Participate in implementation of a new clinical trial management system and development of new workflows aligning with organizational need.
• Conduct regular internal audits of research studies and IRB documentation to assure compliance and FDA inspection readiness.

*Placement in the pay range is based on multiple factors including, but not limited to, relevant years of experience and qualifications. In addition to base pay, there may be additional compensation available for this role, including but not limited to, shift differentials, extra shift incentives, and bonus opportunities. Health and wellness is our passion at MemorialCare—that includes taking good care of employees and their dependents. We offer high quality health insurance plan options, so you can select the best choice for your family. And there’s more...Check out our MemorialCare Benefits for more information about our Benefits and Rewards.

Minimum Requirements

Qualifications/Work Experience:

• Minimum of seven (7) years of experience in regulatory documentation management or clinical research required.
• Knowledge of clinical trial federal, state and local regulations and good clinical practices required.
• Strong project management, analytical, organizational, and problem-solving skills required.
• Excellent time management and ability to prioritize work assignments independently required.
• Excellent interpersonal and communication skills required.

Education/Licensure/Certification:

• Bachelor’s Degree.
• Research certification (e.g., ACRP/CCRP or equivalent) required.