Regulatory Affairs Supervisor — Labeling & Compliance Lead

Cardinal Health, Inc.; United States; On-site; USD 80,000 - 117,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

401k savings plan

Disability coverage – short/long term

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health, Inc. is seeking a Supervisor, Regulatory Affairs to oversee regulatory programs, policies, and procedures across labeling, listings, and compliance for private label and commercial products.

The role emphasizes collaboration with cross-functional teams to minimize risks and ensure supply chain integrity. You will supervise labeling and listing specialists, reinforce internal policies, and coordinate FDA-related submissions like GUDID, UDI, and NDC directories while maintaining

Qualifications

• 4–8 years of experience in pharmaceutical/medical device QA or Regulatory Affairs.
• Bachelor’s degree in a related scientific/technical field.
• Familiarity with FDA CPGs, 21 CFR 11, and USP standard testing.
• Experience with Kallik, FACTS, or Veeva Vault QMS.
• Working knowledge of eDRLS and I4I/A4L software for FDA drug listings.

Responsibilities

• Coordinate daily activities of labeling and listing specialists.
• Reinforce internal policies to support zero-defect quality and regulatory objectives.
• Interact with senior leaders, vendor QA, and legal groups to gain cross-functional consensus.
• Oversee labeling component approvals for private label brands and packaging sections of MBRs.
• Review Prop 65 assessments and substantiations to ensure marketing compliance.
• Manage Package Insert revisions and PKR/PI processes.
• Collaborate on deviations, HHEs, and market-action workflows with QA/clinical safety teams.
• Oversee FDA drug listing submissions and CARES Act reporting activities.
• Maintain GUDID data submissions and Kallik workflow configurations.
• Update SOPs to tighten regulatory compliance and efficiency.
• Lead cross-functional alignment and mentor QA/regulatory staff.
• Negotiate Quality Agreements and liaise with external partners.

Skills

Regulatory Affairs experience

Quality Assurance

Leadership

Cross-functional collaboration

Education

Bachelor’s degree in a related scientific/technical field

Tools

Kallik

FACTS

Veeva Vault QMS

GUDID

CARES Act reporting

Job description

Cardinal Health, Inc. is seeking a Supervisor, Regulatory Affairs to oversee regulatory programs, policies, and procedures across labeling, listings, and compliance for private label and commercial products.

The role emphasizes collaboration with cross-functional teams to minimize risks and ensure supply chain integrity. You will supervise labeling and listing specialists, reinforce internal policies, and coordinate FDA-related submissions like GUDID, UDI, and NDC directories while maintaining