Compliance

• Leads the development and implementation of all CMC regulatory strategy to support global development programs and market applications for cell therapies
• Responsible for ensuring the appropriate execution of CMC regulatory strategy
• Provide strategic and operational leadership and ensure effectiveness of the CMC Regulatory Affairs team
• Lead preparation of CMC-related submission planning, risk assessments, and ensure high-quality, accurate submission documents completed within target timelines
• Build and manage relationships with internal and external stakeholders and work across functions
• Ensure CMC dossiers meet ICH format and local country requirements; stay current with regulatory requirements and initiate process improvements
• Analyze complex CMC issues, interpret and discuss data with cross-functional teams and health authorities

Vice President, CMC Regulatory Affairs

Business Control Manager – Technology Risk & Regulatory Engagement Lead

Business Control Manager – GT Risk & Regulatory Engagement Lead

Business Control Manager – Technology Risk & Regulatory Lead

Quality Specialist – Customer Compliance

Senior Director, Compliance & Ethics – PRISM, Multi-Specialty MSOs