Regulatory Affairs Specialist

McKesson

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

Posted 10/5/2026full-timeRemote • Tennessee • United StatesJuniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory affairs compliance, including knowledge of FDA regulations and GCP requirements. Proficient in managing documentation systems and ensuring compliance with IRB policies and local SOPs.

Highest-signal resume keywords

Regulatory Affairs ComplianceFDA RegulationsGCP DocumentationClinical Research ExperienceIRB Submission Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Documentation ManagementInformed Consent Form DevelopmentProtocol ManagementMedical Terminology KnowledgeProtocol Deviation Processing

Soft Skills

Organizational SkillsTime ManagementCommunication Skills

Tools & Technologies

Document Management Systems

Industry Keywords

Clinical ResearchPharmaceutical IndustrySite ManagementIRB ComplianceSOP Compliance

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
Maintain a full study workload with minimal supervision
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 SOPs for format and content
Modify and/or develop informed consent forms 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 a clinical research, pharmaceutical, or site management organization, focused on regulatory affairs, highly desired
Knowledge of medical terminology highly preferred
Knowledge of FDA and other regulatory processes highly preferred
US-based work authorization implied by the US-based position; sponsorship is not available

Benefits

Comp & perks

Comprehensive Total Rewards package supporting physical, mental, and financial well-being
Annual bonus or long-term incentive opportunities may be offered
Relocation assistance is not available
Sponsorship is not available