Remote Regulatory Affairs Supervisor

Cardinal Health; Augusta (ME); Remote; USD 80,000 - 117,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

401k savings plan

Flexible spending accounts (FSAs)

Health savings account (HSA)

Paid parental leave

Job summary

Cardinal Health is seeking a Supervisor, Regulatory Affairs to oversee labeling approvals, FDA submissions, and regulatory compliance across human drug, medical device, and cosmetic portfolios. This role guides cross-functional teams and ensures adherence to internal policies.

You will supervise labeling and listing specialists, manage quality systems, and coordinate with QA, packaging operations, development, and external vendor QA groups to minimize risk and support uninterrupted supply.

Qualifications

• Experience: 4–8 years in pharmaceutical/medical device Quality Assurance or Regulatory Affairs (Private Label experience preferred).
• Education: Bachelor’s degree in a related scientific/technical field, or equivalent practical work experience preferred.
• Preferred Technical Knowledge: 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

• Labeling Component & Packaging Approval: Oversee QA approvals of labeling components for CAH Pharmaceutical Private Label brands and review Master Batch Records packaging sections.
• Quality Systems, Investigations & Market Action Support: Partner with QA managers to resolve packaging/labeling deviations and support market-action workflows.
• System Administration & Database Integrity: Oversee drug listing activities and manage UDI data submissions in GUDID; update SOPs to tighten compliance.
• Cross-Functional Liaison & Team Leadership: Direct, supervise, and mentor Specialists; coordinate with Quality, Packaging Ops, Development, Sourcing, and external vendor QA groups.

Education

Bachelor's degree in a related scientific/technical field

Tools

Kallik

FACTS

Veeva Vault QMS

eDRLS

I4I/A4L

Job description

Cardinal Health is seeking a Supervisor, Regulatory Affairs to oversee labeling approvals, FDA submissions, and regulatory compliance across human drug, medical device, and cosmetic portfolios. This role guides cross-functional teams and ensures adherence to internal policies.

You will supervise labeling and listing specialists, manage quality systems, and coordinate with QA, packaging operations, development, and external vendor QA groups to minimize risk and support uninterrupted supply.