Remote Regulatory Affairs Supervisor – Labeling & Compliance

Cardinal Health; Cheyenne (WY); 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

Job summary

Cardinal Health is seeking a Supervisor of Regulatory Affairs in the United States to manage regulatory programs and procedures, ensuring compliance across labeling, listings, and FDA submissions. You will collaborate with QA, packaging operations, and development teams to drive compliant solutions.

The role requires 4–8 years in pharma/medical device QA or RA, a Bachelor’s degree, and experience with Kallik, FACTS, or Veeva Vault QMS.

Qualifications

• 4–8 years in pharmaceutical/medical device QA or Regulatory Affairs (RA).
• Bachelor’s degree in a related scientific/technical field.
• Familiarity with FDA compliance policy guides (CPGs), 21 CFR 11, and USP standards.
• Experience with Kallik, FACTS, or Veeva Vault QMS databases.

Responsibilities

• Oversee labeling and listing approvals for CAH Pharmaceutical Private Label brands.
• Review and approve packaging labeling sections in Master Batch Records and repackaging requests.
• Review Prop 65 assessments and substantiations for marketing materials.
• Manage Drug Listing operations, including FDA submissions and CARES Act reporting.
• Lead cross-functional liaison with QA, packaging, product development, and external vendor QA groups.

Skills

Regulatory Affairs

Quality Assurance

Cross-functional collaboration

Education

Bachelor's degree in a related field

Tools

Kallik

FACTS

Veeva Vault QMS

eDRLS

I4I/A4L

Job description

Cardinal Health is seeking a Supervisor of Regulatory Affairs in the United States to manage regulatory programs and procedures, ensuring compliance across labeling, listings, and FDA submissions. You will collaborate with QA, packaging operations, and development teams to drive compliant solutions.

The role requires 4–8 years in pharma/medical device QA or RA, a Bachelor’s degree, and experience with Kallik, FACTS, or Veeva Vault QMS.