Remote Regulatory Affairs Supervisor - Labeling & Compliance

Cardinal Health; Nashville (TN); Remote; USD 80,000 - 117,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

Health savings account (HSA)

401k savings plan

Paid parental leave

Flex spending accounts (FSAs)

Disability coverage

Work-Life resources

Job summary

Cardinal Health seeks a Supervisor, Regulatory Affairs to lead regulatory programs across labeling, listings, and compliance for pharmaceutical private label and medical device products.

You will coordinate approvals for labeling components, manage SPL/NDC/UDI submissions, and monitor evolving FDA standards. The role emphasizes cross-functional leadership, team mentorship, and ensuring timely regulatory outputs in a nationwide remote setting.

Qualifications

• 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.
• 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.

Responsibilities

• Coordinate and supervise daily activities of labeling and listing specialists.
• Administer and reinforce internal policies to support zero-defect quality and regulatory objectives.
• Oversee labeling components and packaging approvals (MBR, PI revisions).
• Review Prop 65 assessments and substantiation to ensure compliance.
• Lead deviation resolution and root-cause analysis with QA teams.
• Support Drug Listing operations and FDA submissions, CARES Act reporting.
• Manage GUDID submissions and Kallik workflows.
• Update SOPs to improve regulatory compliance and efficiency.
• Lead cross-functional alignment with QA, Packaging, Product Development, and external QA vendors.

Skills

Regulatory compliance

FDA regulations

Project coordination

Communication skills

Education

Bachelor’s degree in a related scientific/technical field

Tools

Kallik

FACTS

Veeva Vault QMS

GUDID

Job description

Cardinal Health seeks a Supervisor, Regulatory Affairs to lead regulatory programs across labeling, listings, and compliance for pharmaceutical private label and medical device products.

You will coordinate approvals for labeling components, manage SPL/NDC/UDI submissions, and monitor evolving FDA standards. The role emphasizes cross-functional leadership, team mentorship, and ensuring timely regulatory outputs in a nationwide remote setting.