Research Regulatory Affairs Specialist

McKesson

. Manage and plan regulatory affairs compliance for industry sponsors and/or sites in networks .

Posted 10/9/2026full-timeRemote • Tennessee • United StatesJuniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory affairs compliance, including knowledge of FDA, GCP, IRB policy, and HIPAA. Capable of managing documentation systems and ensuring compliance with strict deadlines in clinical research environments.

Highest-signal resume keywords

Regulatory Affairs ComplianceFDA Regulatory ProcessesGCP Documentation RequirementsIRB Policy KnowledgeClinical Research Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Documentation ManagementInformed Consent Form DevelopmentProtocol ModificationAudit PreparationMedical Terminology Knowledge

Soft Skills

Time ManagementMinimal SupervisionOrganizational Skills

Tools & Technologies

Document Management Systems

Industry Keywords

Clinical ResearchPharmaceuticalSite ManagementCompliance DocumentationProtocol Deviations

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Manage and plan regulatory affairs compliance for industry sponsors and/or sites in networks
Work closely with regulatory affairs management, department director, and/or primary investigators to ensure compliance
Prepare for auditing activities while meeting strict deadlines
Establish and maintain document management systems for regulatory electronic files
Maintain FDA- and GCP-required regulatory documentation for sites, studies, sponsors, and/or networks
Ensure regulatory documentation complies with local Standard Operating Procedures for format and content
Maintain critical documentation for compliance
Modify and/or develop informed consent forms
Update and manage protocol, investigator drug brochure, and consent form modifications or amendments in compliance with IRB policy and HIPAA
Handle time-sensitive correspondence with sponsors and other stakeholders
Organize and process documentation for IRB submission for multiple trials
Process protocol deviations meeting IRB reportable criteria
Submit urgent safety notifications to the IRB
Perform other duties as assigned

Requirements

What you’ll need

High school graduation diploma required
Associate's Degree or higher preferred
Qualified experience may be substituted for education
1+ year work experience in clinical research, pharmaceutical, or site management organization work focused on regulatory affairs highly desired
Knowledge of medical terminology highly preferred
Knowledge of FDA and other regulatory processes highly preferred
Ability to manage a full study workload with minimal supervision
Knowledge of IRB policy and HIPAA compliance
Familiarity with FDA and GCP regulatory documentation requirements
Ability to meet strict deadlines and prepare for auditing activities

Benefits

Comp & perks

Total Rewards package including comprehensive benefits supporting physical, mental, and financial well-being
Competitive compensation package
Annual bonus or long-term incentive opportunities may be offered
Equity may be included in compensation
McKesson benefits offerings