Remote Regulatory Affairs Supervisor: Labeling & Compliance

Cardinal Health; Salem (OR); 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 is seeking a Supervisory role in Regulatory Affairs to manage labeling approvals and regulatory programs across drug, device, and cosmetic portfolios. You will work with cross-functional teams to ensure compliance with FDA standards and listing requirements while guiding a team of specialists.

As a remote nationwide position, you will oversee Prop 65, MBR reviews, and SLP submissions, driving risk reduction and process improvements in a fast-paced environment.

Qualifications

• 4–8 years of experience in pharmaceutical/medical device QA 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.

Responsibilities

• Coordinate and supervise labeling and listing activities and senior specialists.
• Support quality objectives with policy implementation and procedure updates.
• Collaborate across Quality, Packaging Operations, Development, and external vendor QA groups.
• Oversee drug listing activities and FDA submissions, including CARES Act reporting.

Skills

Regulatory knowledge

Quality Assurance

Leadership

Education

Bachelor’s degree or equivalent

Tools

Kallik

FACTS

Veeva Vault QMS

eDRLS

I4I/A4L software

Job description

Cardinal Health is seeking a Supervisory role in Regulatory Affairs to manage labeling approvals and regulatory programs across drug, device, and cosmetic portfolios. You will work with cross-functional teams to ensure compliance with FDA standards and listing requirements while guiding a team of specialists.

As a remote nationwide position, you will oversee Prop 65, MBR reviews, and SLP submissions, driving risk reduction and process improvements in a fast-paced environment.