Supervisor, Reg Affairs

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.

Job Summary

The Supervisor, Regulatory Affairs manages regulatory programs, policies, and procedures to minimize risks and drive uncompromised supply chain integrity. Applying a strong knowledge of regulatory concepts and technical capabilities, the Supervisor collaborates cross-functionally to develop solutions to complex regulatory issues. When creating new standard operating procedures or revising existing practices, the Supervisor is responsible for ensuring alignment within the organization and monitoring adherence to policies.

• Coordinates and supervises the daily activities of labeling and listing senior specialists.
• Administers and reinforces internal policies and procedures to support zero-defect quality and regulatory objectives.
• Interactions normally involve structured information exchange, complex problem resolution, and securing cross-functional consensus with senior leaders, vendor QA, and legal groups.

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.

Cross-Functional Liaison & Team Leadership

• 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.

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

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