Regulatory Affairs Supervisor

Cardinal Health

. Manage regulatory programs, policies, and procedures to minimize risks and drive supply chain integrity .

Posted 10/20/2026full-timeRemote • United StatesMid-LevelSenior💰 $79,700 - $117,200 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing regulatory programs and quality assurance processes within the pharmaceutical and medical device sectors, with a strong focus on compliance, risk management, and cross-functional collaboration.

Highest-signal resume keywords

Regulatory Affairs ManagementQuality Assurance ExperienceFDA Compliance KnowledgeKallik Regulatory LabelingStandard Operating Procedures Development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Programs ManagementQuality AssuranceLabeling ApprovalRisk ManagementSOP Creation and RevisionFDA SubmissionsMaster Batch Records ReviewHealth Hazard EvaluationsPackaging and Labeling ComplianceRoot-Cause Analysis

Soft Skills

Cross-Functional CollaborationMentoringProblem-SolvingLeadershipCommunication

Tools & Technologies

KallikFACTSVeeva Vault QMSEDRLSI4I/A4L Software

Industry Keywords

PharmaceuticalMedical DeviceQuality AssuranceRegulatory ComplianceFDA Compliance Policy Guides21 CFR Part 11USP Standard TestingPrivate Label ExperienceCARES Act ReportingGUDID Medical-Device UDI

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

Manage regulatory programs, policies, and procedures to minimize risks and drive supply chain integrity
Collaborate cross-functionally to develop solutions to complex regulatory issues
Create and revise standard operating procedures and monitor adherence to policies
Coordinate and supervise daily activities of labeling and listing senior specialists
Administer and reinforce internal policies and procedures supporting quality and regulatory objectives
Oversee and assist with QA approvals of labeling components for pharmaceutical private-label brands
Review and approve labeling sections of Master Batch Records and Requests for Repackaging
Review and approve claims, bio-food statements, and California Proposition 65 assessments
Oversee proofing and disposition of Package Insert revisions
Resolve complex packaging and labeling deviations with QA managers
Lead defect-photo, complaint-sample, and root-cause efforts to define market-action limits
Facilitate and draft Health Hazard Evaluations with clinical medical safety experts
Oversee drug listing activities and FDA submissions, including CARES Act reporting and FDA Certification periods
Manage GUDID medical-device UDI submissions and Kallik regulatory labeling workflows
Update SOPs to improve regulatory compliance, efficiency, and quality
Direct, supervise, and mentor Specialists and Senior Specialists
Liaise with Quality, Packaging Operations, Commercial Product & Development, Pharmaceutical Product Sourcing, and external vendor QA groups
Lead discussions regarding Quality Agreements

Requirements

What you’ll need

4–8 years of experience in pharmaceutical/medical device Quality Assurance or Regulatory Affairs (Private Label experience preferred)
Bachelor’s degree in a related scientific/technical field, or equivalent practical work experience preferred
Familiarity with FDA Compliance Policy Guides (CPGs), 21 CFR Part 11, and USP standard testing
Experience with Kallik, FACTS, or Veeva Vault QMS database architectures
Working knowledge of eDRLS and I4I/A4L software applications for FDA drug listing submissions

Benefits

Comp & perks

Medical, dental and vision coverage
Paid time off plan
Health savings account (HSA)
401k savings plan
Access to wages before pay day with myFlexPay
Flexible spending accounts (FSAs)
Short- and long-term disability coverage
Work-Life resources
Paid parental leave
Healthy lifestyle programs