Remote Regulatory Affairs Supervisor – National

Cardinal Health; Lincoln (NE); Remote; USD 80,000 - 117,000; Full time

Benefits offered by this job

Medical, dental & vision

Paid time off

Health savings account

401k plan

Early wage access

FSAs

Disability coverage

Work-life resources

Parental leave

Wellness programs

Job summary

Cardinal Health seeks a Supervisor, Regulatory Affairs to lead regulatory programs across labeling, listings, and product compliance for private label and commercial products. You will supervise labeling and listing specialists and partner with Quality, Packaging Operations, and Development to ensure adherence to FDA regulations and internal SOPs.

This role emphasizes cross-functional collaboration, risk assessment, and process improvements.

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.

Responsibilities

• Coordinate and supervise labeling and listing activities to ensure compliance.
• Oversee and approve labeling components for private label brands and Master Batch Records.
• Review Prop 65 assessments and ensure marketing material compliance.
• Manage drug listing activities and FDA submissions including CARES Act reporting.
• Lead cross-functional liaison with QA, Packaging Operations, Product Development, and external vendor QA groups.
• Develop and refine SOPs to tighten regulatory compliance and process efficiency.
• Provide leadership to Specialists and Senior Specialists within QA and Regulatory teams.

Skills

Regulatory expertise

Cross-functional collaboration

Quality mindset

Education

Bachelor’s degree in a related field

Tools

Kallik

FACTS

Veeva Vault QMS

GUDID system

eDRLS

I4I/A4L

Job description

Cardinal Health seeks a Supervisor, Regulatory Affairs to lead regulatory programs across labeling, listings, and product compliance for private label and commercial products. You will supervise labeling and listing specialists and partner with Quality, Packaging Operations, and Development to ensure adherence to FDA regulations and internal SOPs.

This role emphasizes cross-functional collaboration, risk assessment, and process improvements.