Partnering as lead counsel directly with the PT Global Head of Quality and PT Global Head of Regulatory to provide legal risk guidance on critical quality and regulatory matters, including quality governance structures, change control oversight, and significant compliance trends to prevent enforcement actions and protect product integrity worldwide. Key responsibilities of this role may include, but not be limited to, the following: Advising on global regulatory and compliance matters relating to FDA, EMA, or other global requirements for manufacturing compliance, regulatory enforcement actions, risk management, and commercial operations involving manufacturing practices—including Current Good Manufacturing Practices (cGMP), quality system requirements, and other quality-related issues and agreements.