Remote Regulatory Affairs Supervisor – Labeling & Compliance

Cardinal Health; Atlanta (GA); Remote; USD 80,000 - 117,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401k savings plan

Paid time off

Job summary

Cardinal Health seeks a Supervisor, Regulatory Affairs to lead labeling approvals, drug listings, and FDA submissions across private label and marketed products. You will collaborate with QA, Legal, and Commercial Product teams to uphold compliance and quality standards.

The role supervises labeling specialists, reviews Prop 65 and claims for accuracy, and maintains regulatory data systems while updating SOPs to ensure best practices across the organization.

Qualifications

• Bachelor’s degree in a related scientific/technical field.
• 4–8 years pharma/medical device QA or regulatory affairs.
• Familiarity with FDA Compliance Policy Guides (CPGs) and 21 CFR Part 11.

Responsibilities

• Coordinate and supervise labeling and listing senior specialists.
• Review Prop 65 assessments to ensure compliance.
• Oversee drug listing activities and FDA submissions including CARES Act reporting.
• Lead cross-functional regulatory partnerships and SOP updates.

Skills

Regulatory affairs

Quality Assurance

FDA regulations

GxP knowledge

Education

Bachelor’s degree in scientific/technical field

Tools

Kallik

FACTS

Veeva Vault QMS

eDRLS

Job description

Cardinal Health seeks a Supervisor, Regulatory Affairs to lead labeling approvals, drug listings, and FDA submissions across private label and marketed products. You will collaborate with QA, Legal, and Commercial Product teams to uphold compliance and quality standards.

The role supervises labeling specialists, reviews Prop 65 and claims for accuracy, and maintains regulatory data systems while updating SOPs to ensure best practices across the organization.