Remote Regulatory Affairs Supervisor

Cardinal Health; Jackson (MS); 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

Job summary

Cardinal Health seeks a Supervisor, Regulatory Affairs to lead labeling and listing programs, ensuring compliance across CAH Private Label products and FDA submissions. You will oversee SOPs, support regulatory risk assessment, and coordinate with QA, legal, and external vendors to secure regulatory alignment.

The role emphasizes cross-functional collaboration, adherence to FDA requirements, and continuous improvement within a nationwide remote framework, with salary visibility and growth

Qualifications

• Experience: 4–8 years of experience 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

• 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.

Skills

Regulatory affairs experience

FDA compliance knowledge

Quality Assurance knowledge

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 Supervisor, Regulatory Affairs to lead labeling and listing programs, ensuring compliance across CAH Private Label products and FDA submissions. You will oversee SOPs, support regulatory risk assessment, and coordinate with QA, legal, and external vendors to secure regulatory alignment.

The role emphasizes cross-functional collaboration, adherence to FDA requirements, and continuous improvement within a nationwide remote framework, with salary visibility and growth