Regulatory Affairs Manager

Monday - Friday, 8:00am-5:00pm
Hybrid, must reside in Arizona
Regulatory experience required
Manages a team that executes the strategy of regulatory. Oversees all regulatory matters. Develops and executes the goals and strategy to ensure the organization complies with applicable regulations and the efficient management of regulatory of all research service-lines. Develops regulatory processes and systems to ensure that all necessary licensing, filings and certifications are processed and monitored. Establishes regulatory policies and procedures and partners with compliance to establish same for monitoring. Ensures compliance with existing regulations and leads the respective implementations. Investigates and addresses any legal changes, reported issues of non-compliance, and is responsible for the related policy and or workflow change.
Provides in-depth knowledge, expertise, ongoing support, education and training to regulatory and clinical research staff regarding the regulatory conduct of clinical research studies. This position is responsible for the development and implementation of department operating procedures for the regulatory department. Serves as regulatory expert to interdepartmental and external agencies, ensuring regulatory compliance for all research studies at HRI. Facilitates communication between the Regulatory Affairs department and other departmental leadership to align training and staff development to meet key timelines and milestones. Develops and monitors budget for regulatory department.
ESSENTIAL FUNCTIONS
Manages day-to-day operations for the Regulatory Affairs staff. Assigns workloads to the Regulatory Affairs coordinators. Ensures work is completed in a timely manner following institutional policies/procedures, regulations and guidance documents. Develops and implements departmental processes incorporating the Lean Methodology where appropriate and good clinical practice for the conduct of clinical trials.
Recruits and retains talented regulatory staff through positive role-modeling, fostering peer relationships, staff education, and participating in preceptor and/ or mentor programs thereby creating an environment for quality practice. Fosters collaborative partnerships/relationships with all departments within HonorHealth Research Institute. Interviews, selects, and recommends hiring of personnel. Administers performance evaluation in collaboration with the Director. Independently administers staff discipline through the second stage (written); participates with management in following stages. Edits and approves time via Laborworkx. Evaluates utilization and availability of equipment, supplies, and space. Monitors and maintains appropriate inventory levels.
Identifies need and develops respective new policy and workflows. Responsible to collaborate with Directors, Research Quality, Regulatory & Compliance, and research clinic to establish and implement process improvement.
Develops and monitors budgets, identifies fiscally responsible efficiencies, and implements same. Serves as a resource to other, including staff, providers, sponsors, vendors and visitors. Facilitates inter/intra departmental collaboration, communication and promotes problem solving.
Performs other duties as assigned.
EDUCATION
Bachelors or at least 5 years clinical research experience Required
Masters in healthcare area or at least 5 years clinical research experience Preferred
EXPERIENCE
4 years experience in clinical research, including data coordination, document and regulatory management, regulatory compliance and regulatory assurance Required
6 years Regulatory Affairs experience Preferred
LICENSE AND CERTIFICATIONS
American Association of Cardiovascular and Pulmonary Rehab–Certified Cardiac Rehabilitation Professional - Certification Clinical Research Profession by SoCRA Preferred
Certified Clinical Research Coordinator - Certification Clinical Research Coordinator Preferred