Regulatory Analyst 1

University of Miami

Regulatory Analyst I preparing, submitting, and maintaining regulatory documentation for clinical trials at University of Miami/UHealth.

Posted 7/15/2026full-timeRemote • Florida • 🇺🇸 United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Affairs within the clinical research industry, ensuring compliance with FDA, NIH, and other regulations while effectively managing regulatory documentation throughout the clinical trial lifecycle.

Highest-signal resume keywords

Regulatory Affairs ExperienceClinical Trials KnowledgeRegulatory Documentation ManagementEffective Communication SkillsData Analysis Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory DocumentationClinical Trials ProcessesData CollectionData OrganizationData Analysis

Soft Skills

Interpersonal Relationship ManagementEffective Communication

Tools & Technologies

Microsoft Office

Industry Keywords

FDA RegulationsNIH RegulationsSOP ComplianceContract Research Organization (CRO)Study Start-UpStudy Closure

About the role

Key responsibilities & impact

Prepares, submits, and ensures proper maintenance of regulatory documentation for clinical trials from study start-up through study closure.
Facilitates the process of preparing required regulatory documentation for initial and subsequent study submissions.
Provides regulatory support for multiple clinical trials from study start-up through study closure.
Generates and updates essential regulatory documents including the editing of consent forms appropriately based on required institutional language and/or study revisions.
Attends site visits conducted by sponsor/Contract Research Organization (CRO) for matters concerning regulatory documents.
Ensures compliance of general and study specific regulatory related processes with SOPs, FDA, NIH, and other applicable regulations.

Requirements

What you’ll need

Bachelor's degree in relevant field
Minimum 2 years Regulatory Affairs experience in the clinical research industry or equivalent combination of studies and relevant work experience inclusive of substantial experience in regulatory affairs.
Ability to maintain effective interpersonal relationships.
Ability to communicate effectively in both oral and written form.
Skill in collecting, organizing, and analyzing data.
Proficiency in computer software (i.e., Microsoft Office)
Ability to establish and maintain effective working relationships with diverse set of internal/external cross functional co-workers, managers, and clients.
Knowledge of processes associated with clinical trials.
Knowledge of applicable federal, state, and local rules and regulations.

Benefits

Comp & perks

medical
dental
tuition remission
competitive salaries