Regulatory Compliance Manager

Meharry Medical College; Nashville (TN); On-site; USD 90,000 - 120,000; Full time

Job summary

Meharry Medical College seeks a Regulatory Compliance Manager to support the Executive Director for the Center of Excellence for Clinical & Translational Research in planning, execution, and coordination of regulatory activities related to clinical research projects.

The role involves preparing regulatory submissions, maintaining essential regulatory documentation, and ensuring compliance with ICH-GCP, FDA regulations, IRB requirements, and applicable laws and policies.

Qualifications

• Bachelor's degree in life sciences, health sciences, nursing, pharmacy, public health, regulatory affairs, or related field required.
• Advanced degree (MS, MPH, PharmD, or equivalent) preferred.

Responsibilities

• Prepare, compile, maintain, and support submissions related to regulatory filings under guidance.
• Maintain regulatory binders and essential documents per ICH-GCP SOPs.
• Review regulatory documents for completeness and accuracy; ensure submission requirements are met.
• Serve as regulatory contact for study sponsors, IRBs, and regulatory agencies.
• Support IRB submissions, continuing reviews, amendments, and reportable events.
• Monitor FDA, OHRP, IRBs, ClinicalTrials.gov for current regulations.
• Support ClinicalTrials.gov registrations and results reporting where applicable.
• Provide guidance on regulatory requirements to study teams.
• Identify project needs, track timelines, and manage day-to-day workload with leadership.
• Assist with pharmacovigilance documentation and safety reporting.

Skills

Communication skills

Detail-oriented

Regulatory knowledge

Project coordination

Microsoft Office

Education

Bachelor's degree in life sciences

Advanced degree preferred

Tools

Regulatory software

ClinicalTrials.gov

Job description

The Regulatory Compliance Manager will support the Executive Director for the Center of Excellence for Clinical & Translational Research in the planning, execution, and coordination of regulatory activities associated with clinical research projects conducted by the Organization.

Responsibilities include supporting regulatory submissions, maintaining essential regulatory documentation, and ensuring compliance with study protocols, International Council for Harmonization Good Clinical Practice (ICH-GCP) guidelines, U.S. Food and Drug Administration (FDA) regulations, Institutional Review Board (IRB) requirements, the Common Rule (45 CFR 46), HIPAA, applicable federal and state regulations, and organizational policies and procedures.

Essential Functions (Principal Duties and Job Responsibilities)

• Prepare, compile, maintain, and support submissions related to INDs, IDEs, protocol amendments, continuing reviews, annual reports, safety reports, and other regulatory filings under the guidance of The Executive Director for the Center of Excellence for Clinical & Translational Research.
• Maintain regulatory binders, electronic regulatory files, investigator/site regulatory records, and essential documents, including investigator qualifications, training records, financial disclosures, delegation logs, laboratory certifications, and other required documentation in accordance with ICH-GCP and organizational SOPs.
• Review regulatory documents for completeness, consistency, and accuracy, and collaborate with project team members to ensure submission requirements are met.
• Serve as a regulatory contact for study sponsors, IRBs, regulatory agencies, and other oversight bodies, as applicable.
• Support IRB submissions, continuing reviews, amendments, reportable events, and study closure activities.
• Monitor updates from the FDA, Office for Human Research Protections (OHRP), IRBs, ClinicalTrials.gov, and other applicable regulatory authorities to ensure ongoing compliance with current regulations, guidance documents, and industry standards.
• Support clinical trial registration and results reporting activities in ClinicalTrials.gov, as applicable.
• Support communications and submissions to the FDA under the direction of Regulatory Affairs leadership when required.
• Provide guidance and support to study teams regarding regulatory requirements, processes, and documentation.
• Identify project needs, track timelines, and manage day-to-day workload in collaboration with the Executive Director for the Center of Excellence for Clinical & Translational Research.
• Provide regulatory support to the Safety Team and assist with the preparation, tracking, and submission of serious adverse event reports, safety reports, and other pharmacovigilance-related documentation in accordance with organizational SOPs and sponsor requirements.
• Assist with preparation for sponsor, regulatory authority, and internal audits and inspections, including documentation review and response activities.
• Follow organizational SOPs and procedural documents consistently and contribute to process improvement initiatives.
• Perform other duties as assigned.

Knowledge, Skills and Abilities Required

Effective oral and written communication skills in English
Excellent interpersonal skills
Uncompromising attention to detail and the ability to think analytically
Organization and planning ability
Sound problem‑solving and decision‑making skills
Medical/therapeutic area knowledge and medical terminology
High level of interpersonal awareness and diplomacy
Strong knowledge of clinical research regulations and guidelines, including FDA regulations (21 CFR Parts 11, 50, 54, 56, 312, 812, and applicable sections of 814), ICH‑GCP, HIPAA, and 45 CFR 46 (Common Rule).
Experience with an institutional review board (IRB) and/or human subjects' research
Experience writing, reviewing, developing, or implementing policies, processes, and procedures
Proficiency in Microsoft Office Suite and the ability to learn and effectively utilize regulatory and clinical research software systems
The ability to work unsupervised / independently on several projects.

Knowledge, Skills, Abilities Preferred

A minimum of two (2) years of experience in clinical research, pharmaceutical, biotechnology, academic medical center, or healthcare setting is preferred. Experience preparing, maintaining, and managing regulatory documentation and submissions in support of clinical research studies is preferred.

Education and Experience Required

Bachelor's degree in life sciences, health sciences, nursing, pharmacy, public health, regulatory affairs, or related field required.

Education and Experience Preferred

Advanced degree (MS, MPH, PharmD, or equivalent) preferred.

Licensure, Certification or Registration Required

Current certification in Good Clinical Practice (GCP) training (or ability to obtain within 90 days of hire). Current Human Subjects Protection (HSP) training (e.g., CITI Program or equivalent) or ability to obtain within 90 days of hire. Must maintain all required institutional, sponsor, and regulatory training throughout employment.

Licensure, Certification or Registration Preferred

Certified Clinical Research Professional (CCRP) - Society of Clinical Research Associates (SOCRA)
Certified Clinical Research Coordinator (CCRC) - Association of Clinical Research Professionals (ACRP)
Regulatory Affairs Certification (RAC) - Regulatory Affairs Professionals Society (RAPS)
Demonstrated knowledge of FDA regulations (21 CFR Parts 11, 50, 54, 56, 312, 812), ICH E6(R3) Good Clinical Practice, HIPAA, and applicable federal regulations governing human subjects research.