Supervisor, Reg Affairs

Cardinal Health; Austin (TX); Remote; USD 80.000 - 117.000; Vollzeit

Benefits dieser Stelle

Medical, dental and vision coverage

401k savings plan

Paid time off plan

Health savings account (HSA)

Flexible spending accounts (FSAs)

Disability coverage

Work-Life resources

Paid parental leave

Zusammenfassung

Cardinal Health seeks a Supervisor, Regulatory Affairs to lead labeling and listing programs across human drug, medical device, and cosmetic portfolios. You will supervise senior specialists, ensure compliant submissions, and maintain cross-functional alignment with QA, packaging operations, development, and external vendor QA groups.

You will oversee QA approvals of labeling components, prop 65 assessments, drug listing submissions and GUDID/Kallik workflows, while updating SOPs to enhance

Qualifikationen

• 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.
• Familiarity with FDA Compliance Policy Guides (CPGs), 21 CFR Part 11, and USP standard testing.
• Working knowledge of eDRLS and I4I/A4L software applications for FDA drug listing submissions.

Aufgaben

• Coordinate and supervise labeling and listing activities for QA specialists and senior specialists.
• Oversee QA approvals of labeling components for private label brands and review MBRs for packaging changes.
• Review Prop 65 assessments and ensure compliance of marketing materials.
• Manage drug listing activities and FDA submissions, including CARES Act reporting where applicable.
• Lead cross-functional alignment with Quality, Packaging Operations, Product Development, Sourcing, and external vendor QA groups.

Kenntnisse

Regulatory Affairs

Quality Assurance

Cross-functional collaboration

Leadership

Ausbildung

Bachelor’s degree in a related scientific/technical field

Tools

Kallik

FACTS

Veeva Vault QMS

eDRLS

I4I/A4L

Jobbeschreibung

Country-wide Remote

US-Nationwide-FIELD

Full time

20189244

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
• 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

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.

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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.

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