At Roche, we believe that every patient deserves access to life-changing innovations. As a global healthcare leader operating across pharmaceuticals and diagnostics, we combine cutting-edge science, advanced technology, and a passion for improving lives to address some of the world’s most challenging medical needs. Driven by our commitment to research and sustainable healthcare solutions, we foster an inclusive, collaborative environment where diverse teams are empowered to question the status quo, drive continuous improvement, and redefine what is possible in contemporary medicine.

The Pharma

Technical (PT) Operations Global MSAT & Engineering group takes bold steps to modernize technical operations to enable Roche to deliver medicines for patients more quickly, efficiently and reliably. PTT shapes and accelerates technology innovation and product lifecycle management for tomorrow, while standardizing and driving operational excellence in PT today. As the Principal Expert, you will act as the technical authority and global strategist for Direct Materials Certification and Filing.

This position provides high-level technical oversight, proactively implementing enterprise-wide solutions for complex problems and ensuring global compliance with the most stringent Health Authority regulations.

The Principal

Expert drives the modernization of materials across the entire PT network, ensuring a robust and flexible supply chain from a compliance perspective to support Product Health across the product life cycle.

Global Governance: Accountable and responsible for the global design and strategic execution of Certification & Filing business processes, ensuring standardization across Biologics, Synthetic Molecules and Cell & Gene Therapy area.



Leads the development of enterprise-level Direct Materials Certification & Filing Strategies, serving as the primary bridge for Regulatory global compliance and Health Authority requirements ensuring simplification and alignment of approaches. Drives modernization and technology innovation by influencing stakeholders (including senior stakeholders) to drive successful program implementation.

Applies data-driven knowledge to the complex regulatory challenges, particularly in high-risk areas such as virus-risk, BSE/TSE, and biological-derived material compliance.

Expert Review: Serves as the final reviewer and approver for enterprise-wide compliance, technical, and scientific documents, holding legalization signature authority for Roche products. Maintains a state of global inspection readiness at all times and spearheads the implementation of major compendia changes or responses to Health Authority audits.

Strategic Alignment: Accountable for building high-level collaborations and work relationships between key stakeholders including External Quality, Procurement, Quality, Manufacturing, and Regulatory.

Experience &

Education: BS/MS/PhD in Science, Engineering or Management with at least 8 years of experience in the pharmaceutical, pharmaceutical or medical device industry including extensive experience in regulatory filings and material specifications is beneficial Strategic Leadership: 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. Relocation benefits are not available for this posting #

📌 Direct Materials Regulatory Filings Principal Expert (Mississauga)
🏢 Roche
📍 Mississauga