Manager - Regulatory Affairs
About The Position
The Manager of Regulatory Affairs manages a team responsible for executing regulatory strategy and oversees regulatory matters across research service lines. The role develops and executes goals and strategies to support regulatory compliance and efficient management of research regulatory activities. It establishes processes, systems, policies, and procedures for licensing, filings, certifications, and regulatory monitoring, and partners with compliance teams to support oversight. The manager ensures compliance with current regulations, leads implementation efforts, investigates legal changes and reported non-compliance, and drives related policy or workflow changes. The position provides expertise, ongoing support, education, and training to regulatory and clinical research staff on the regulatory conduct of clinical research studies. It develops and implements department operating procedures, serves as a regulatory expert for internal departments and external agencies, and supports compliance across all HonorHealth Research Institute studies. The manager facilitates communication with departmental leadership to align training and staff development with key timelines and milestones, and develops and monitors the regulatory department budget. This is a hybrid position requiring residence in Arizona. The schedule is Monday through Friday, 8:00 a.m. to 5:00 p.m., on the day shift.
Requirements
- Bachelor's degree or at least 5 years of clinical research experience.
- At least 4 years of experience in clinical research, including data coordination, document and regulatory management, regulatory compliance, and regulatory assurance.
- Must reside in Arizona.
Nice To Haves
- Master's degree in a healthcare area or at least 5 years of clinical research experience.
- 6 years of Regulatory Affairs experience.
- American Association of Cardiovascular and Pulmonary Rehab–Certified Cardiac Rehabilitation Professional certification.
- Certification as a Clinical Research Professional by SoCRA.
- Certified Clinical Research Coordinator certification.
Responsibilities
- Manage the day-to-day operations of Regulatory Affairs staff and assign workloads to Regulatory Affairs coordinators.
- Ensure work is completed promptly and in accordance with institutional policies and procedures, regulations, and guidance documents.
- Develop and implement departmental processes, incorporating Lean Methodology where appropriate and good clinical practice for clinical trials.
- Recruit and retain regulatory staff through role-modeling, fostering peer relationships, staff education, and participation in preceptor or mentor programs.
- Interview, select, and recommend personnel for hire.
- Administer performance evaluations in collaboration with the Director and independently administer staff discipline through the second stage (written), participating with management in later stages.
- Edit and approve time via Laborworkx.
- Evaluate the utilization and availability of equipment, supplies, and space, and monitor and maintain appropriate inventory levels.
- Identify needs for new policies and workflows and collaborate with Directors, Research Quality, Regulatory & Compliance, and research clinics on process improvement.
- Develop and monitor budgets, identify fiscally responsible efficiencies, and implement them.
- Provide support as a resource to staff, providers, sponsors, vendors, and visitors.
- Facilitate interdepartmental and intradepartmental collaboration, communication, and problem-solving.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
