About The Position

As a Regulatory SME (Subject Matter Expert) within the Center of Excellence, you will 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

  • University degree in a Natural Science (Chemistry, Biology, or related) and have successfully transitioned into a Regulatory Affairs career.
  • Deep understanding of Hazard Communication (80% focus).
  • Solid grasp of Dangerous Goods frameworks (20% focus).
  • Ability to dissect complex legal texts and apply them to technical product data.
  • Ability to explain the "why" behind a regulation to both a lab scientist and a business executive.
  • Ability to thrive in a global "Center of Excellence" environment, working closely with Monitoring squads and Operational teams.

Nice To Haves

  • Other university backgrounds will also be valued.

Responsibilities

  • 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.
  • Apply your 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-proof" the Roche portfolio.
  • Support implementation projects at all levels, ensuring that operational teams (OETs) 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.

Benefits

  • Pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Sant Cugat del Vallès. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.
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