Manager Research Regulatory Affairs| Innovate and Research

Kettering Health•Kettering, OH

21h•Onsite

About The Position

Kettering Health is a not-for-profit system of 13 medical centers and more than 120 outpatient facilities serving southwest Ohio. We are committed to transforming the health care experience with high-quality care for every stage of life. Our service-oriented mission is in action every day, whether it’s by providing care in our facilities, training the next generation of health care professionals, or serving others through international outreach.

Requirements

Minimum of 4 years of progressive experience in clinical research, including FDA-regulated research.
Demonstrated experience with industry sponsored clinical trials, including drugs and devices required.
In-depth knowledge of FDA regulations, ICH-GCP E6(R3), and clinical research compliance requirements.
Proficiency with electronic regulatory systems, CTMS platforms, and delegation of authority management.
Proven ability to maintain audit-ready regulatory documentation and effectively support audits and inspections.
Strong organizational, analytical, and written and verbal communication skills.
Ability to manage multiple studies and regulatory priorities simultaneously across a variety of therapeutic areas.

Nice To Haves

Prior experience supervising, mentoring, or training staff preferred, with demonstrated readiness to build and lead a regulatory team.
Experience developing institutional regulatory infrastructure, SOPs, templates, and training programs.
Prior involvement in FDA inspections, sponsor audits, or institutional audits with successful outcomes

Responsibilities

Prepare, review, and submit regulatory documents (IRB, FDA, IND, IDE, protocol amendments, annual reports, safety reports) for clinical trials.
Serve as the primary liaison with external regulatory agencies and oversight bodies, including IRBs, the FDA, sponsors, and monitors.
Develop, implement, and maintain regulatory SOPs, workflows, templates, and processes to ensure consistent regulatory compliance across all studies.
Provide regulatory strategy and guidance for industry-sponsored trials, investigator-initiated studies, physician-held INDs, and device studies.
Support and expand institutional capability for physicians to act as IND or IDE sponsors, including guidance on FDA submissions, correspondence, and ongoing compliance obligations.
Ensure all regulatory submissions are accurate, complete, and compliant with FDA regulations and ICH-GCP E6(R3).
Maintain up-to-date regulatory files, including delegation of authority logs, protocol signatures, investigator agreements, and essential documents.
Monitor and track regulatory and research training requirements (CITI, GCP, FDA-required training, device/IND-specific training) for all study personnel.
Maintain audit-ready status for all departmental regulatory documentation and lead preparation for internal audits, sponsor audits, and regulatory inspections.
Manage and optimize use of electronic regulatory systems (eRegulatory), Clinical Trial Management Systems (CTMS), and other compliance tracking tools.
Collaborate closely with principal investigators, clinical research staff, legal/compliance partners, and sponsors to ensure regulatory compliance throughout the study lifecycle.
Stay current on FDA regulations, guidance documents, ICH-GCP standards, and emerging regulatory trends affecting clinical research.
Other duties as assigned aligned with Kettering’s strategic objectives.