Remote Regulatory Affairs Supervisor: Labeling & Compliance

Cardinal Health; Juneau (AK); Remote; USD 80,000 - 117,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401k plan

Paid time off

Health savings account

Flexible spending accounts

Disability coverage

Parental leave

Job summary

Cardinal Health in the United States seeks a Supervisor, Regulatory Affairs to lead labeling approvals and maintain FDA submissions across drugs, devices, and cosmetics. You will oversee labeling components, listings, and compliance programs with cross-functional partners to mitigate regulatory risk.

You will supervise specialists, refine SOPs, and drive quality governance while aligning with legal and QA teams.

Qualifications

• Experience in pharmaceutical/medical device QA or regulatory affairs.
• Bachelor's degree in a related field or equivalent.
• Knowledge of FDA policies and quality systems.

Responsibilities

• Supervise labeling and listing specialists daily.
• Ensure compliance with FDA, Prop 65, and internal SOPs.
• Collaborate cross-functionally to resolve regulatory issues.
• Maintain and improve drug and device listings in regulatory databases.
• Lead quality agreements and vendor QA coordination.

Skills

Regulatory knowledge

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree in a related scientific/technical field

Tools

Kallik

FACTS

Veeva Vault QMS

eDRLS

I4I/A4L

Job description

Cardinal Health in the United States seeks a Supervisor, Regulatory Affairs to lead labeling approvals and maintain FDA submissions across drugs, devices, and cosmetics. You will oversee labeling components, listings, and compliance programs with cross-functional partners to mitigate regulatory risk.

You will supervise specialists, refine SOPs, and drive quality governance while aligning with legal and QA teams.