Regulatory Affairs Coordinator

McKesson

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

Posted 10/9/2026full-timeRemote • Tennessee • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing regulatory affairs compliance, ensuring adherence to FDA and GCP standards, and maintaining critical documentation for clinical operations. Proficient in document management systems and capable of meeting strict deadlines while providing regulatory support.

Highest-signal resume keywords

Regulatory Affairs Compliance ManagementFDA Regulatory DocumentationGood Clinical Practice (GCP)Document Management SystemsStandard Operating Procedures (SOPs)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory DocumentationAuditing PreparationDocument Signature ProcessingRegulatory SupportDeadline Management

Soft Skills

Customer Service

Tools & Technologies

Electronic Signature Platform

Certifications & Qualifications

Associate DegreeBachelor’s Degree

Industry Keywords

Clinical OperationsRegulatory AffairsCompliance Documentation

About the role

Key responsibilities & impact

Manage and plan regulatory affairs compliance for industry sponsors and/or sites in networks
Work with regulatory affairs management, department director, and/or primary investigators to ensure compliance
Prepare for auditing activities while meeting strict deadlines
Process regulatory document signature requests through an electronic signature platform
Track documents pending site regulatory signatures
Provide site-level regulatory support to Clinical Operations sites and internal department managers
Establish and maintain document management systems for regulatory paper and electronic files
Maintain FDA and GCP-required regulatory documentation for individual sites, studies, sponsors, and/or networks
Ensure regulatory documentation complies with local SOPs for format and content
Maintain updated physician credentials and other critical documentation
Triage site requests for regulatory support and identify the correct pathway for issue resolution

Requirements

What you’ll need

Associate Degree required; Bachelor’s Degree preferred
Regulatory experience preferred
Customer service experience preferred
Knowledge of FDA and Good Clinical Practice (GCP) regulatory documentation
Ability to ensure regulatory documentation complies with local Standard Operating Procedures (SOPs)
Ability to manage strict deadlines and prepare for auditing activities
Ability to maintain updated physician credentials and critical compliance documentation

Benefits

Comp & perks

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
Total Rewards package