Remote Regulatory Affairs Supervisor

Cardinal Health; Bismarck (ND); Remote; USD 80,000 - 117,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Access to wages before pay day with my

Flexible spending accounts (FSAs)

Short- and long-term disability

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health is seeking a Supervisor, Regulatory Affairs to oversee labeling and listing programs, driving compliance across human drug, medical device, and cosmetic portfolios. You will lead SOP updates, QA collaboration, and cross-functional regulatory solutions to minimize risk and protect supply chain integrity.

The role supervises senior specialists, aligns with QA, Packaging Operations, Commercial Product & Development, and external vendor QA groups.

Qualifications

• Experience: 4–8 years of experience in pharmaceutical/medical device Quality Assurance 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.

Skills

Regulatory Affairs

Quality Assurance

FDA Compliance

Private Label

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 and listing programs, driving compliance across human drug, medical device, and cosmetic portfolios. You will lead SOP updates, QA collaboration, and cross-functional regulatory solutions to minimize risk and protect supply chain integrity.

The role supervises senior specialists, aligns with QA, Packaging Operations, Commercial Product & Development, and external vendor QA groups.