Senior Manager, Sponsor Regulatory Affairs & Trials

30 Shea Medical Center; Scottsdale (AZ); On-site; USD 120,000 - 170,000; Full time

Job summary

HonorHealth is seeking an experienced leader to oversee the Office of Regulatory Affairs and Research Oversight within the Division of Institutional Research. This role directs regulatory strategy, trial startup, safety oversight, and multi-site sponsor operations to ensure FDA compliance and inspection readiness.

The candidate will mentor a team, develop SOPs, manage regulatory documentation, and collaborate across IRB, legal, finance, and operations to enable efficient sponsorship of

Qualifications

• 6 years of progressive clinical research experience required.
• 3 years of leadership experience in regulatory affairs, sponsor operations, quality systems, or clinical trial administration required.
• 3 years of experience with IND, IDE, FDA submissions, or sponsor held trials required.
• 3 years of experience building teams, systems, and operational infrastructure preferred.
• Regulatory certifications (CCRP/CCRC/RAC/PMP) preferred

Responsibilities

• Lead regulatory strategy for institutionally sponsored trials across drug, device, biologic, behavioral, and observational studies.
• Oversee IND/IDE submissions, amendments, annual reports, safety reports, and protocol changes.
• Ensure regulatory readiness and sponsor oversight across multiple sites and networks.
• Develop governance, SOPs, and training to ensure compliance and inspection readiness.
• Collaborate with IRB, legal, contracting, finance, and operations to align study operations

Skills

Regulatory affairs

Clinical trials

FDA submissions

Quality systems

Leadership

Education

Bachelors

Masters in health administration, public health, regulatory science, business, nursing, pharmacy, law, or related field

Job description

HonorHealth is seeking an experienced leader to oversee the Office of Regulatory Affairs and Research Oversight within the Division of Institutional Research. This role directs regulatory strategy, trial startup, safety oversight, and multi-site sponsor operations to ensure FDA compliance and inspection readiness.

The candidate will mentor a team, develop SOPs, manage regulatory documentation, and collaborate across IRB, legal, finance, and operations to enable efficient sponsorship of