Regulatory Affairs Specialist I

McKesson

. Establishes and maintains a document management system for regulatory electronic files.

Posted 4/3/2026full-timeRemote • Tennessee • 🇺🇸 United StatesJuniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Establishes and maintains a document management system for regulatory electronic files.
Maintains FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks.
Ensures all regulatory documentation is compliant with local Standard Operating Procedures (SOPs) for format and content.
Maintains critical documentation ensuring compliance.
Modifies and/or develops informed consent forms and updates and manages protocol, investigator drug brochure and consent form modifications or amendments in compliance with IRB policy and HIPAA.
Organizes and processes documentation for IRB submission for multiple trials.
Processing of Protocol Deviations that meet the IRB reportable criteria.
Submits urgent safety notifications to the IRB.
Other duties as assigned.

Requirements

What you’ll need

Associate's Degree or higher is preferred, high school graduation diploma required - qualified experience may be substituted for education.
1+ year work experience in a clinical research, pharmaceutical, site management organization highly desired focused in required regulatory affairs.
Knowledge of medical terminology, FDA, other regulatory processes highly preferred.

Benefits

Comp & perks

Comprehensive benefits to support physical, mental, and financial well-being.
Total Rewards offerings serve the different needs of our diverse colleague population.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

document management systemregulatory documentationinformed consent formsprotocol modificationsinvestigator drug brochureIRB submissionprotocol deviationssafety notificationscompliancemedical terminology

Certifications

Associate's Degreehigh school graduation diploma