Remote Regulatory Affairs Supervisor — Labeling & Compliance

Cardinal Health; Santa Fe (NM); Remote; USD 80,000 - 117,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

401k savings plan

Access to wages before pay day with my

Flexible spending accounts (FSAs)

Disability coverage

Work-Life resources

Paid parental leave

Job summary

Cardinal Health is seeking a Supervisory Regulatory Affairs professional to lead labeling and listing programs across Rx, OTC, and private label portfolios. The role demands coordination with QA, packaging operations, and development teams to ensure regulatory compliance and supply chain integrity.

You will oversee SOPs, provide cross-functional guidance, and supervise labeling specialists while aligning with FDA requirements and internal policies.

Qualifications

• 4–8 years in pharmaceutical/medical device QA or regulatory affairs (Private Label experience preferred).
• Bachelor’s degree in a related scientific/technical field or equivalent experience.
• Familiarity with FDA Compliance Policy Guides (CPGs), 21 CFR Part 11, and USP standard testing.
• Experience with Kallik, FACTS, or Veeva Vault QMS architectures.
• Working knowledge of eDRLS and I4I/A4L software for FDA drug listing submissions.

Responsibilities

• Oversee labeling components approvals (Rx/OTC) for CAH Private Label brands.
• Review and approve Master Batch Records labeling sections and packaging approvals.
• Review Prop 65 assessments and validate marketing claims for compliance.
• Manage Package Insert revisions and document updates.

Skills

Regulatory Affairs

Quality Assurance

Private Label experience

FDA knowledge

Education

Bachelor’s degree in science/technical field

Tools

Kallik

FACTS

Veeva Vault QMS

eDRLS

I4I/A4L

Job description

Cardinal Health is seeking a Supervisory Regulatory Affairs professional to lead labeling and listing programs across Rx, OTC, and private label portfolios. The role demands coordination with QA, packaging operations, and development teams to ensure regulatory compliance and supply chain integrity.

You will oversee SOPs, provide cross-functional guidance, and supervise labeling specialists while aligning with FDA requirements and internal policies.