Senior Regulatory Compliance Manager, Clinical Research

Meharry Medical College; Lexington (MA); On-site; USD 110,000 - 140,000; Full time

Job summary

Meharry Medical College is hiring a Regulatory Compliance Manager to support the Center of Excellence for Clinical & Translational Research in planning, coordinating regulatory activities for clinical studies. You will help with regulatory submissions, maintain essential documents, and ensure compliance with ICH-GCP, FDA regulations, IRB requirements, and 45 CFR 46.

You will liaise with sponsors and oversight bodies, support audits, and guide study teams on regulatory processes, while working

Qualifications

• Bachelor’s degree in life sciences or related field is required.
• Advanced degree (MS/ MPH/ PharmD) preferred.
• GCP training certification required or within 90 days of hire.
• HSP training (CITI or equivalent) or within 90 days of hire.
• Experience with IRB submissions and regulatory documentation preferred.
• Two years of clinical research or healthcare setting experience preferred.
• Proficiency in MS Office and regulatory software systems.

Responsibilities

• Prepare and support submissions related to INDs, IDEs, amendments, continuing reviews, and safety reports.
• Maintain regulatory binders, electronic files, and essential documents per ICH-GCP and SOPs.
• Review regulatory documents for completeness and coordinate with teams to meet submission requirements.
• Act as regulatory contact for sponsors, IRBs, agencies, and oversight bodies.
• Support IRB submissions, continuing reviews, amendments, and study closure; monitor regulatory updates.
• Assist with FDA communications under Regulatory Affairs leadership.
• Provide guidance on regulatory requirements and track timelines; manage day-to-day workload with ED.
• Support Safety Team and assist with SAE reports and pharmacovigilance documentation.
• Assist with sponsor, regulatory authority, and internal audits; participate in process improvements.
• Perform other duties as assigned.

Skills

Communication

Interpersonal skills

Attention to detail

Organization & planning

Problem solving

Medical knowledge

Diplomacy

Regulatory knowledge

IRB experience

Policy writing

MS Office / reg software

Independent work

Education

Bachelor’s degree in life sciences/related field

Advanced degree (MS/MPH/PharmD) preferred

Job description

Meharry Medical College is hiring a Regulatory Compliance Manager to support the Center of Excellence for Clinical & Translational Research in planning, coordinating regulatory activities for clinical studies. You will help with regulatory submissions, maintain essential documents, and ensure compliance with ICH-GCP, FDA regulations, IRB requirements, and 45 CFR 46.

You will liaise with sponsors and oversight bodies, support audits, and guide study teams on regulatory processes, while working