Remote Regulatory Affairs Supervisor – Labeling & Compliance

Cardinal Health; Montpelier (VT); 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 in Regulatory Affairs to manage regulatory programs and procedures that minimize risk and ensure supply chain integrity. You will collaborate with Quality, Packaging Operations, Commercial Product & Development, and external QA groups to drive compliant labeling, listings, and device submissions.

The role requires a strong regulatory foundation, experience with FDA guidelines, and leadership of a cross-functional team to deliver compliant documents and

Qualifications

• 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 preferred.
• Familiarity with FDA Compliance Policy Guides (CPGs), 21 CFR Part 11, and USP standard testing.

Responsibilities

• Coordinate labeling and listing activities; supervise specialists.
• Support quality systems, deviations, and market-action workflows as needed.
• Oversee FDA submissions, CARES Act reporting, and GUDID data management.
• Lead cross-functional alignment and regulatory liaison with QA, operations, and development teams.

Skills

Regulatory affairs

Quality assurance

Cross-functional leadership

Documentation & SOPs

FDA compliance knowledge

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 in Regulatory Affairs to manage regulatory programs and procedures that minimize risk and ensure supply chain integrity. You will collaborate with Quality, Packaging Operations, Commercial Product & Development, and external QA groups to drive compliant labeling, listings, and device submissions.

The role requires a strong regulatory foundation, experience with FDA guidelines, and leadership of a cross-functional team to deliver compliant documents and