Regulatory Affairs Supervisor

🔥 13 hours ago

🇺🇸 United States – Remote

💵 $79.7k - $117.2k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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Cardinal Health

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1971

📦 Logistics

🏭 Manufacturing

🏥 Healthcare

💰 $78M Post-IPO Debt on 2006-08

Logistics • Manufacturing • Healthcare

Cardinal Health is a global healthcare services and products company. It provides a comprehensive range of healthcare services, including medical supply distribution, pharmaceutical distribution, and logistics solutions to various healthcare facilities such as hospitals, community health centers, and ambulatory surgery centers. Additionally, Cardinal Health offers a variety of medical products and pharmaceutical services. The company also focuses on innovative solutions to enhance healthcare delivery, through services like patient support, pharmacy management, and advanced therapy solutions. Cardinal Health is committed to supporting healthcare providers in delivering quality patient care while optimizing operational efficiency.

📋 Description

• Manage regulatory programs, policies, and procedures to minimize risks and drive supply chain integrity • Collaborate cross-functionally to develop solutions to complex regulatory issues • Create and revise standard operating procedures and monitor adherence to policies • Coordinate and supervise daily activities of labeling and listing senior specialists • Administer and reinforce internal policies and procedures supporting quality and regulatory objectives • Oversee and assist with QA approvals of labeling components for pharmaceutical private-label brands • Review and approve labeling sections of Master Batch Records and Requests for Repackaging • Review and approve claims, bio-food statements, and California Proposition 65 assessments • Oversee proofing and disposition of Package Insert revisions • Resolve complex packaging and labeling deviations with QA managers • Lead defect-photo, complaint-sample, and root-cause efforts to define market-action limits • Facilitate and draft Health Hazard Evaluations with clinical medical safety experts • Oversee drug listing activities and FDA submissions, including CARES Act reporting and FDA Certification periods • Manage GUDID medical-device UDI submissions and Kallik regulatory labeling workflows • Update SOPs to improve regulatory compliance, efficiency, and quality • Direct, supervise, and mentor Specialists and Senior Specialists • Liaise with Quality, Packaging Operations, Commercial Product & Development, Pharmaceutical Product Sourcing, and external vendor QA groups • Lead discussions regarding Quality Agreements

🎯 Requirements

• 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 database architectures • Working knowledge of eDRLS and I4I/A4L software applications for FDA drug listing submissions

🏖️ Benefits

• 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