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 define what compliance looks like for our product portfolio.
Key Responsibilities
* Lead technical evaluation of new and changing regulations (primarily GHS/CLP) and translate complex legal text into a clear Regulatory Opinion.
* Apply scientific background to assess how chemical compositions and product designs are impacted by hazard communication standards.
* Identify upcoming regulatory trends and define the long‑term compliance strategy to future‑prove the Roche portfolio.
* Support implementation projects at all levels, ensuring operational teams understand how to apply regulatory opinions to compliance outputs (e.g., SDS).
* Serve as the primary technical expert for internal queries, prioritizing work based on risk and business impact.
Who You Are
* Hold a university degree in a natural science (Chemistry, Biology, or related) and have transitioned into a regulatory affairs career (other backgrounds valued).
* Deep understanding of Hazard Communication (80% focus) and solid grasp of Dangerous Goods frameworks (20% focus).
* Enjoy dissecting complex legal texts and applying them to technical product data.
* Effective communicator, able to explain the \"why\" behind regulations to lab scientists and business executives.
Collaborative Partner
You thrive in a global Center of Excellence environment, working closely with monitoring squads and operational teams.
Location
Primary location: Sant Cugat del Vallès. Additional location details will be provided later in the hiring process.
Roche is an Equal Opportunity Employer.
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