About The Position

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position As a Regulatory SME (Subject Matter Expert) within the Center of Excellence, you act as the vital link between regulatory requirements and technical implementation. You will lead the organization in interpreting GHS/CLP and Dangerous Goods regulations, ensuring that Roche Diagnostics products are classified correctly and compliant globally. You don’t just follow rules; you define what compliance looks like for our specific product portfolio, now and in the future.

Requirements

  • The Scientist-turned-Regulator: You hold a University degree in a Natural Science (Chemistry, Biology, or related) and have successfully transitioned into a Regulatory Affairs career. Other university background will be also valued.
  • The GHS/CLP Expert: You have a deep understanding of Hazard Communication (80% focus) and a solid grasp of Dangerous Goods frameworks (20% focus).
  • The Analytical Thinker: You enjoy dissecting complex legal texts and applying them to technical product data.
  • The Effective Communicator: You can explain the "why" behind a regulation to both a lab scientist and a business executive.
  • The Collaborative Partner: You thrive in a global "Center of Excellence" environment, working closely with Monitoring squads and Operational teams.

Responsibilities

  • Detailed Regulatory Assessment: Lead the technical evaluation of new and changing regulations (primarily GHS/CLP). Translate complex legal text into a "Regulatory Opinion" that provides a clear, auditable rationale for Roche Diagnostics.
  • Product Impact Analysis: Apply your scientific background to assess how chemical compositions and product designs are impacted by hazard communication standards.
  • Strategic Compliance Roadmap: Identify upcoming regulatory trends and define the long-term compliance strategy to "future-proof" the Roche portfolio.
  • Cross-Functional Implementation: Support implementation projects at all levels, ensuring that operational teams (OETs) understand how to apply regulatory opinions to compliance outputs (e.g. SDS).
  • Internal Point of Contact: Serve as the primary technical expert for internal queries, prioritizing work based on risk and business impact.
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