Direct Materials Regulatory Filings Principal Expert

• Accountable and responsible for the global design and strategic execution of Certification & Filing business processes.
• Leads the development of enterprise-level Direct Materials Certification & Filing Strategies.
• Drives modernization and technology innovation by influencing stakeholders across PTD, PTM, PTT, PTC and PTQ.
• Applies data-driven knowledge to the most complex regulatory challenges.
• Serves as the final reviewer and approver for enterprise-wide compliance, technical, and scientific documents.
• Maintains a state of global inspection readiness at all times.
• Accountable for building high-level collaborations and work relationships between key stakeholders including External Quality, Procurement, PTC, QC, QA, Manufacturing, and Regulatory.

• BS/MS/PhD in Science, Engineering or Management with at least 8 years of experience in the pharmaceutical, biopharmaceutical or medical device industry.
• Extensive experience in regulatory filings and material specifications is required.
• Proven ability to combine strategic clarity with innovative thinking, aligning with matrix leadership model and coaching capabilities.
• Expert-level knowledge of international standards (ICH, ISO), Pharma GMP operations, and Health Authority regulations.
• Advanced knowledge of Operational Excellence tools e.g., statistical methods, FMEA, Six Sigma, Lean Principles.
• Proven experience working in and leading high-impact teams in a global matrix setting.
• Exceptional ability to build connections, influence business needs, and foster a collaborative environment across the enterprise.
• Committed to creating an inclusive environment where team members feel safe, valued, and empowered to perform their best.

Demonstrates expertise in Regulatory Filings, Material Specifications, and International Standards, while fostering collaboration and strategic execution in a global matrix environment. Proven ability to apply Operational Excellence tools and maintain compliance with Health Authority regulations.