Remote Regulatory Affairs Supervisor — Compliance & Labeling

Cardinal Health; Columbus (OH); Remote; USD 80,000 - 117,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401k savings plan

Paid time off plan

HSA

Job summary

Cardinal Health seeks a Supervisor, Regulatory Affairs to manage regulatory programs, policies, and procedures across drug, device, and cosmetic portfolios. You will supervise labeling and listing specialists, ensure zero-defect quality, and coordinate cross-functional regulatory activities with QA, operations, development, and external vendors.

The role emphasizes collaboration, adherence to FDA standards, and ongoing improvement of SOPs.

Qualifications

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

Responsibilities

• Coordinate and supervise daily activities of labeling and listing specialists.
• Oversee QA approvals of labeling components and Master Batch Records reviews.
• Review Prop 65 claims and ensure marketing material compliance.
• Oversee drug listing activities and FDA submissions.
• Lead regulatory liaison between QA, Packaging Operations, Product Development, and external vendor QA groups.

Skills

Regulatory Affairs

Quality Assurance

Private Label experience

Pharmaceuticals

Education

Bachelor’s degree in a related scientific/technical field

Tools

Kallik

FACTS

Veeva Vault QMS

eDRLS

I4I/A4L

Job description

Cardinal Health seeks a Supervisor, Regulatory Affairs to manage regulatory programs, policies, and procedures across drug, device, and cosmetic portfolios. You will supervise labeling and listing specialists, ensure zero-defect quality, and coordinate cross-functional regulatory activities with QA, operations, development, and external vendors.

The role emphasizes collaboration, adherence to FDA standards, and ongoing improvement of SOPs.