Remote Regulatory Affairs Supervisor

Cardinal Health; Phoenix (AZ); Remote; USD 80,000 - 117,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401k savings plan

Paid time off plan

Health savings account (HSA)

Flexible spending accounts (FSAs)

Short- and long-term disability

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health seeks a Supervisor, Regulatory Affairs to lead labeling approvals and product listings across drug, device, and cosmetic portfolios. You will oversee the regulatory workflows, coordinate cross-functional teams, and ensure compliance with FDA standards and state requirements.

The role emphasizes SOP updates, cross-functional collaboration with QA, packaging operations, and external vendor QA groups, and mentoring junior specialists to maintain zero-defect quality.

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.
• 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

• Coordinates and supervises the daily activities of labeling and listing senior specialists.
• Administers and reinforces internal policies and procedures to support zero-defect quality and regulatory objectives.
• Interactions normally involve structured information exchange, complex problem resolution, and securing cross-functional consensus with senior leaders, vendor QA, and legal groups.
• Oversee drug listing activities for CAH Pharmaceutical Private Label products, providing guidance and review to support accurate and timely FDA submissions including CARES Act reporting and FDA Certification period.
• Manage GUDID data submissions and Kallik workflows within regulatory labeling systems.
• Regularly update SOPs to tighten regulatory compliance and streamline processes.

Skills

Regulatory affairs experience

FDA compliance knowledge

Kallik/Facts/Veeva Vault

eDRLS/I4I/A4L software

Education

Bachelor’s degree in a related scientific/technical field

Tools

Kallik

FACTS

Veeva Vault QMS

Job description

Cardinal Health seeks a Supervisor, Regulatory Affairs to lead labeling approvals and product listings across drug, device, and cosmetic portfolios. You will oversee the regulatory workflows, coordinate cross-functional teams, and ensure compliance with FDA standards and state requirements.

The role emphasizes SOP updates, cross-functional collaboration with QA, packaging operations, and external vendor QA groups, and mentoring junior specialists to maintain zero-defect quality.