Manager Research Regulatory Affairs| Innovate and Research

Ketering Health Main Campus|Kettering|Full Time|Days

• 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.

• 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.
• 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