Clinical Trial Regulatory Lead

Meharrry Medical College; Nashville (TN); On-site; USD 95,000 - 125,000; Full time

Job summary

Meharry Medical College seeks a Regulatory Compliance Manager to support the Center of Excellence for Clinical & Translational Research in planning, executing, and coordinating regulatory activities for clinical studies. Responsibilities include submissions, documentation, and ensuring compliance with FDA, ICH-GCP, IRB, and related regulations.

The role offers on-site work at the main Nashville campus, with a focus on collaboration with the Executive Director and study teams to maintain rigorous

Qualifications

• Bachelor's degree required in life sciences or related field.
• Advanced degree preferred.

Responsibilities

• Prepare and maintain submissions for regulatory filings (INDs, IDEs, amendments, continuing reviews, annual reports, safety reports).
• Maintain regulatory binders and essential documents per ICH-GCP and SOPs.
• Serve as regulatory contact for sponsors, IRBs, and regulatory bodies.
• Support IRB submissions, continuing reviews, amendments, and reportable events.
• Monitor regulatory updates to ensure ongoing compliance with current regulations.
• Assist with sponsor, regulatory authority, and internal audits and inspections.
• Provide guidance to study teams on regulatory requirements and documentation.
• Track timelines and manage day-to-day workload with leadership.

Skills

Regulatory knowledge

ICH-GCP

FDA regulations

IRB experience

Policy development

Communication

Attention to detail

Organizational skills

Problem solving

Education

Bachelor's degree in life sciences/health sciences/ regulatory affairs

Advanced degree (MS/MPH/PharmD) preferred

GCP certification

HSP training (CITI or equivalent)

Tools

Microsoft Office

Regulatory/clinical research software

ClinicalTrials.gov

Job description

Meharry Medical College seeks a Regulatory Compliance Manager to support the Center of Excellence for Clinical & Translational Research in planning, executing, and coordinating regulatory activities for clinical studies. Responsibilities include submissions, documentation, and ensuring compliance with FDA, ICH-GCP, IRB, and related regulations.

The role offers on-site work at the main Nashville campus, with a focus on collaboration with the Executive Director and study teams to maintain rigorous