Manager, Regulatory Operations

Lead, coach, and develop Regulatory Operations team members, including specialists and assistants, while overseeing workload allocation, study assignments, and team performance.

Partner with Regulatory Operations leadership and Quality Assurance to establish departmental goals and deliver regulatory milestones supporting study startup, conduct, maintenance, and closeout.

Oversee regulatory submissions to ensure accuracy, completeness, compliance, and timely delivery across assigned studies and sites.

Develop, maintain, and improve standard operating procedures (SOPs), work instructions, templates, and training materials to promote consistency, quality, and scalability.

Manage relationships and serve as a key point of contact for IRBs, Institutional Biosafety Committees (IBCs), sponsors, CROs, and other regulatory stakeholders.

Oversee the preparation and submission of new study applications, informed consent documents, protocol amendments, investigator brochures, continuing review reports, closure reports, safety reports, protocol deviations, waivers, and other required documentation.

Coordinate expanded access study submissions to the U.S. Food and Drug Administration (FDA), as assigned, and manage follow-ups, inquiries, and outstanding regulatory requirements.

Maintain complete, accurate, and inspection-ready Investigator Site Files (ISFs), in paper or electronic format, throughout the study lifecycle.

Monitor key performance indicators, including submission turnaround times, aging items, and quality findings, and implement corrective actions and process improvements with cross-functional partners.

Act as an escalation point for complex regulatory matters and facilitate timely resolution of issues involving IRBs, IBCs, the FDA, sponsors, CROs, and internal teams.

Participate in quarterly SOP committee meetings, contribute regulatory and data insights, and update procedures as needed.

Collaborate with clinical site teams, shared services, regional leadership, and other departments to support audits, deadlines, electronic systems, special projects, and regulatory workflow improvements.

Coordinate study closeout visits and ensure all associated regulatory documentation and follow-up activities are completed.

Support accurate regulatory tracking and reporting through systems and platforms such as FileMaker, CITI, study portals, and electronic signature tools.