Supervisor, Reg Affairs

Cardinal Health; United States; On-site; 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)

Disability coverage

Work-Life resources

Paid parental leave

Job summary

Cardinal Health is seeking a Regulatory Affairs professional to ensure end-to-end labeling approvals and product listings across drug, medical device, and cosmetic portfolios. The role safeguards brand integrity while aligning with federal and state regulations and listing requirements.

The position partners with Quality, Packaging Operations, Commercial Product & Development, and external QA groups to manage regulatory workflows, SOPs, and submissions, including SPL, NDC, and UDI processes.

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; experience with Kallik, FACTS, or Veeva Vault QMS databases; working knowledge of eDRLS and I4I/A4L software for FDA drug listings.

Responsibilities

• Oversee labeling component & packaging approval for CAH Pharmaceutical Private Label brands; review Master Batch Records and packaging labeling sections.
• Support QA investigations, deviation resolution, root-cause analysis, and market action planning.
• Manage drug listing operations, GUDID data submissions, FDA submissions, and updates to SOPs for regulatory compliance.

Skills

Regulatory affairs

Quality assurance

FDA compliance

Education

Bachelor’s degree in a related scientific/technical field

Tools

Kallik

FACTS

Veeva Vault QMS

eDRLS

I4I/A4L

Job description

Job Summary

What Regulatory Affairs contributes to Cardinal Health Regulatory Affairs ensures total commercial and post-market compliance by performing end-to-end labeling approvals and managing mandatory product listings across human drug, medical device, and cosmetic portfolios. This function applies strong regulatory expertise to safeguard brand integrity, maintain federal and state regulatory alignment, and ensure compliance across private label and commercialized products. The Regulatory Affairs operations team plans, oversees, and executes critical regulatory workflows—including artwork review, Structured Product Labeling (SPL), National Drug Code (NDC) directory maintenance, Unique Device Identification (UDI) submissions, and cosmetic establishment/product listings. Regulatory Affairs works closely with other internal partners to closely monitor changing FDA standards, state labeling mandates, and listing requirements to identify compliance risks, drive standard operating excellence, and maintain database integrity across all commercial lines.

Responsibilities

• Labeling Component & Packaging Approval Rx and OTC Operations: Oversee and assist with QA approvals of labeling components for CAH Pharmaceutical Private Label brands. Packaging approvals: Perform review and approval of labeling sections of Master Batch Records (MBR) and Requests for Repackaging. Prop 65 & Claim Substantiation: Review and approve claims, bio-food statements, and California Proposition 65 assessments to ensure marketing material compliance. Package Insert (PI) Management: Oversee proofing and disposition of Package Insert revisions.
• Quality Systems, Investigations & Market Action Support: Deviation Resolution: Partner cross-functionally with QA managers to resolve complex packaging/labeling deviations. Lead efforts to procure defect photographs, secure complaint samples, and establish clear root-cause scope to define market action limits. Health Hazard Evaluations (HHEs): Facilitate and draft HHEs in collaboration with clinical medical safety experts to support potential market-action workflows.
• System Administration & Database Integrity: Drug Listing Operations: Oversee drug listing activities for CAH Pharmaceutical Private Label products, providing guidance and review to support accurate and timely FDA submissions including CARES Act reporting and FDA Certification period. GUDID & Kallik Systems: Manage the Medical Device Unique Device Identification (UDI) data submissions to GUDID and maintain regulatory labeling workflows within Kallik management system. SOP & Workflow Refinements: Regularly update Standard Operating Procedures (SOPs) to tighten regulatory compliance and streamline processes for efficiency and improved quality.
• Team Supervision: Direct, supervise, and mentor Specialists and Senior Specialists within the Quality Assurance and Regulatory compliance teams. Cross-Functional Alignment: Act as a primary regulatory liaison between Quality, Packaging Operations, Commercial Product & Development, Pharmacuetical Product Sourcing, and external vendor QA groups (e.g., Sandoz, Innovative Labs). Quality Agreements: Lead collaborative discussions regarding Quality Agreements, to ensure strategic external alignment.

Qualifications

• Experience: 4–8 years of experience in pharmaceutical/medical device Quality Assurance or Regulatory Affairs (Private Label experience preferred).
• Education: Bachelor’s degree in a related scientific/technical field, or equivalent practical work experience preferred.
• Preferred Technical Knowledge: 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.

Compensation

Anticipated salary range: $79,700 - $117,200 Bonus eligible: No

Benefits

Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Application Window

Application window anticipated to close: 12/20/2026

Cultural Commitment

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day.

Cardinal Health is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

Company Overview

Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities. We are a crucial link between the clinical and operational sides of healthcare, delivering end‑to‑end solutions and data‑driving insights that advance healthcare and improve lives every day. With deep partnerships, diverse perspectives and innovative digital solutions, we build connections across the continuum of care. With more than 50 years of experience, we seize the opportunity to address healthcare's most complicated challenges — now, and in the future.