Sr. Regulatory Analyst

University of Miami; Miami (FL); On-site; USD 60,000 - 95,000; Full time

Job summary

An established industry player is seeking a Sr. Regulatory Analyst to join their dynamic team at the UHealth Medical Campus in Miami. This full-time position offers an exciting opportunity to support cancer-related research by ensuring compliance with regulatory standards. The role involves managing submissions to review committees, coordinating with study teams, and developing training programs for staff. With a focus on regulatory affairs, this position is perfect for organized professionals with a passion for research and compliance. Enjoy competitive salaries and comprehensive benefits while contributing to impactful research initiatives.

Benefits

Medical Insurance

Dental Insurance

Tuition Remission

Qualifications

• 3+ years of experience in Regulatory Affairs in research.
• Strong organizational and communication skills required.

Responsibilities

• Provide regulatory support for research studies and documentation management.
• Design training programs for research staff and develop SOPs.

Skills

Regulatory Affairs

Organizational Skills

Communication Skills

Knowledge of NCI Guidelines

Familiarity with Medical Terminology

Education

Bachelor’s Degree

Tools

Microsoft Office

Job description

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Job Overview

The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full-Time Sr. Regulatory Analyst at the UHealth Medical Campus in Miami, FL. The role involves supporting the Population Sciences Research Operations Office of Regulatory Services/Behavioral and Community-Based Shared Research of the Sylvester Comprehensive Cancer Center with submissions to various review committees for cancer-related studies.

Primary Duties & Responsibilities

1. Provide regulatory support for research studies, including communication with regulators and documentation management.
2. Obtain initial regulatory packets from investigators or CROs.
3. Design and conduct training programs for research staff.
4. Develop SOPs and address research compliance issues.
5. Verify credentials of study personnel and ensure documentation accuracy.
6. Assist with protocol submissions and maintain study documentation.
7. Coordinate communication and documentation with study teams and sponsors.
8. Organize and store protocol files and correspondence.
9. Prepare response letters for review committees.
10. Support audit responses and attend regulatory meetings.
11. Perform additional duties as assigned.

Required Qualifications

• Bachelor’s Degree.
• At least three years of Regulatory Affairs experience in research or equivalent.
• CRP certification preferred; strong organizational and communication skills.
• Relevant education, certifications, or work experience considered.

Knowledge, Skills, and Abilities

• Knowledge of NCI guidelines, IRB policies, and industry regulations.
• Ability to manage multiple tasks in a fast-paced environment.
• Familiarity with medical terminology and research protocols.
• Proficiency with Microsoft Office.

Additional Information

The university offers competitive salaries and benefits, including medical, dental, and tuition remission. We are an Equal Opportunity Employer. Employment is full-time, staff position, with a pay grade of H9. The role is classified as Mid-Senior level in a full-time capacity within the Higher Education industry.