At Roche you can show up as yourself, embraced for the unique qualities you bring. At Global Regulatory Affairs our aspiration is to be the world's best Regulatory organization, championing patient access to the world's best diagnostics. Focus of our work is the global approval of in-vitro-diagnostics of the Elecsys Core reagent immunoassay product portfolio. Our dynamic team manages regulatory projects as well as overarching regulatory topics. Shape Strategic Direction: You will steer the strategic direction and represent the Regulatory Affairs department in international, interdisciplinary teams to foster an effective and successful working environment
Manage Global Product Registrations: You will manage product registrations across Europe, the United States, and China, while supporting broader worldwide registration efforts
Act as a Key Interface: You will prepare and submit pre-market applications to the FDA or Notified Bodies, serving as the primary liaison to general health authorities
Leverage International Synergies: To achieve efficient global approvals,



you will collaborate closely with colleagues in Germany, Switzerland, and the US—both intra-departmentally and with global Regulatory Affairs teams
A Bachelor's or Master's degree in Life Sciences, Data Science, or a related field
A minimum of 5 years of experience within Regulatory, R&D;, Quality, Operations, or Clinical environments
Mindset & Skills: Proven track record in agile project management, exceptional self-organization, and the ability to effectively balance and prioritize multiple overlapping projects
Excellent command of English (written and spoken) for daily global collaboration; Employment Type: Full-Time; Temporary for 18 months (parental leave replacement)
Bei Global Regulatory Affairs ist es unser Anspruch, die weltweit beste Regulatory-Organisation zu sein und den Patientenzugang zu den weltweit besten Diagnostika zu fördern. Du steuerst die strategische Ausrichtung und vertrittst den Berei

📌 Regulatory Affairs Project Manager (España)
🏢 Roche
📍 España