Direct Materials Regulatory Filings Principal Expert

Roche; Mississauga; On-site; CAD 180,000 - 240,000; Full time

Job summary

Roche in Mississauga is seeking a Principal Expert to serve as the technical authority for Direct Materials Certification & Filing, providing global oversight and ensuring regulatory compliance across biologics, synthetic molecules, and cell & gene therapy.

You will lead enterprise-wide strategies, influence senior stakeholders, drive data-driven regulatory solutions, and maintain inspection readiness while aligning QA, procurement, and manufacturing for product health across the lifecycle.

Qualifications

• BS/MS/PhD in Science, Engineering or Management with at least 8 years in pharma or medical devices.
• Extensive experience in regulatory filings and material specifications is beneficial.
• Strong knowledge of international standards (ICH, ISO) and Health Authority requirements.

Responsibilities

• Global Governance: design and execution of Certification & Filing processes across Biologics, Synthetic Molecules, and Cell & Gene Therapy.
• Strategy Development: lead enterprise Direct Materials Certification & Filing strategies for regulatory compliance alignment.
• Stakeholders Influence: drive modernization and technology innovation with senior stakeholders.
• Complex Problem Solving: apply data-driven analysis to high-risk regulatory challenges.
• Expert Review: acts as final reviewer for enterprise-wide compliance and keeps signing authority.
• Compliance Leadership: maintain global inspection readiness and respond to Health Authority audits.
• Strategic Alignment: foster high-level collaborations among External Quality, Procurement, Quality, Manufacturing, and Regulatory.

Skills

Strategic leadership

Regulatory knowledge

Communication

E2E thinking

Stakeholder influence

GMP expertise

Regulatory compliance

Education

BS/MS/PhD in Science/Engineering/Management

Tools

Statistical methods

FMEA

Six Sigma

Lean Principles

Job description

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 modern 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.

The Opportunity

• 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.
• Strategy Development: 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.
• Stakeholders Influence: Drives modernization and technology innovation by influencing stakeholders (including senior stakeholders) to drive successful program implementation.
• Complex Problem Solving: 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.
• Compliance Leadership: 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.

Who you are

• 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.
• Expertise: 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.
• E2E Thinking: Proven experience working in and leading high-impact teams in a global matrix setting.
• Outstanding Communicator and Influencer: Exceptional ability to build connections, influence business needs, and foster a collaborative environment across the enterprise.
• Inclusive and Open Minded: Committed to creating an inclusive environment where team members feel safe, valued, and empowered to perform their best.

Relocation benefits are not available for this posting