Direct Materials Regulatory Filings Principal Expert

The Pharma Technical 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 lifecycle. 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 PTC area. Strategy Development: Leads the development of enterprise-level Direct Materials Certification & Filing Strategies, serving as the primary bridge to PTR for 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) across PTD, PTM, PTT, PTC and PTQ to drive successful program implementation. Complex Problem Solving: Applies data-driven knowledge to the most 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, PTC, QC, QA, 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, biopharmaceutical or medical device industry. Extensive experience in regulatory filings and material specifications is required. 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 The expected salary range for this position based on the primary location of California is $114,700 - 212,900. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

Acts as the global technical authority and strategist for Direct Materials Certification and Filing to ensure global compliance with Health Authority regulations. Drives the modernization of materials across the PT network and manages high-level collaborations between quality, procurement, and regulatory stakeholders.

Requires a BS, MS, or PhD in Science, Engineering, or Management with at least 8 years of experience in the pharmaceutical or medical device industry. Must possess expert-level knowledge of ICH/ISO standards, GMP operations, and advanced operational excellence tools.

• Annual Bonus

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Regulatory Filings
• Direct Materials Certification
• Global Compliance
• Stakeholder Influence
• Complex Problem Solving
• Strategic Leadership
• International Standards
• Pharma GMP Operations
• Operational Excellence
• FMEA
• Six Sigma
• Lean Principles
• Matrix Leadership
• Technical Oversight
• Scientific Document Review
• Supply Chain Compliance
• Program Implementation
• Influencing Skills
• Influencing Without Authority
• Supply Chain
• Open Mindset
• Material Compliance
• Strategy Development
• Medical Devices
• Six Sigma Methodology
• Auditing
• Biology
• Biopharmaceuticals
• Management
• Business Process
• Good Manufacturing Practices
• Procurement
• Failure Mode And Effects Analysis
• Governance
• Leadership
• Innovation
• Product Lifecycle Management
• Operations
• Pharmaceuticals
• Coaching
• Statistical Methods
• Strategic Alignment
• Filing
• Quality Control

• Healthcare
• Science & Research
• Engineering
• Management & Leadership
• Manufacturing
• Principal
• Unclassified Specialized Occupation

Formation minimale

Baccalauréat

Expérience minimale

10+ ans

Langue de l’offre

anglais

Heures de travail

40 heures par semaine