Vice President of Regulatory Affairs

Job Summary

A company is looking for a Vice President, Regulatory & Quality.

Key Responsibilities

• Lead and mentor the Regulatory Affairs and Quality Assurance teams to ensure alignment with corporate objectives
• Develop and implement regulatory strategies and processes for product commercialization and compliance
• Oversee the Quality Management System (QMS) and drive continuous improvement initiatives

Required Qualifications

• BA/BS in life sciences; advanced degree (MS, PhD) preferred
• 20+ years of management experience in global quality assurance and regulatory affairs
• Experience with product submissions in multiple therapeutic areas and NGS technology
• Extensive knowledge of regulatory compliance requirements (ISO, CLIA, CAP, GxP)
• Proven experience in global regulatory filings and negotiations with regulatory agencies