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Supervisor, Reg Affairs

Cardinal Health
Remote, USA
Full-time
Mid · 4–8 years experience
Remote
Discovered 4 days ago

Full Job Posting

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
  • 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 anticipated to close: 12/20/2026 if interested in opportunity, please submit application as soon as possible.
  • The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
  • 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.
  • To read and review this privacy notice click here
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Preferred 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.
  • Bonus eligible: No
  • 4–8 years of experience in pharmaceutical/medical device Quality Assurance or Regulatory Affairs (Private Label experience preferred).

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