Remote Regulatory Affairs Supervisor

Cardinal Health; Madison (WI); Remote; USD 80,000 - 117,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Disability coverage

Work-Life resources

Job summary

Cardinal Health seeks a Regulatory Affairs Supervisor to lead regulatory programs, policies, and procedures that minimize risk and protect supply chain integrity. The role collaborates across Quality, Packaging Operations, Product Development, and external QA groups to ensure compliant labeling and drug listing activities.

You will supervise labeling and listing specialists, refine SOPs, and monitor adherence to regulatory policies while maintaining regulatory database integrity and facilitating

Qualifications

• 4–8 years of experience in pharmaceutical/medical device QA or Regulatory Affairs.
• 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.
• Working knowledge of eDRLS and I4I/A4L software applications for FDA drug listing submissions.

Responsibilities

• Coordinates and supervises labeling and listing activities within QA and regulatory teams.
• Supports SOP updates and regulatory compliance initiatives across product lines.
• Acts as regulatory liaison between Quality, Operations, Commercial/Product Development, and external QA groups.
• Oversees drug listing submissions, GUDID/UDI data management, and regulatory database integrity.

Skills

Regulatory affairs expertise

Quality Assurance collaboration

Cross-functional leadership

Regulatory documentation

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 Regulatory Affairs Supervisor to lead regulatory programs, policies, and procedures that minimize risk and protect supply chain integrity. The role collaborates across Quality, Packaging Operations, Product Development, and external QA groups to ensure compliant labeling and drug listing activities.

You will supervise labeling and listing specialists, refine SOPs, and monitor adherence to regulatory policies while maintaining regulatory database integrity and facilitating