At Roche you can show up as yourself, embraced for the unique qualities you bring. At Roche Global Regulatory Affairs we strive to be the world's best Regulatory organization, championing patient access to the world's best diagnostics. Our team is tasked with regulatory projects as well as overarching regulatory topics with specific focus in Companion Diagnostics. You develop and manage parts of comprehensive integral regulatory submissions and registration plans. You have the ability to interpret and apply understanding of the regulators' thinking to projects and apply strategies to the different needs of different regions without significant guidance. Who you areYou have a Bachelor’s / Master degree in Life Science, Data Science or related subject or equivalent experience. You have 3-5 years experience with PhD degree,



5-7 with Masters degree and 6-8 years with Bachelor degree in the field of IVDs/Medical devices/Pharma/Biopharmaceutical with significant experiences in Regulatory Affairs You have demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices.You have knowledge of the European, US, China and other international regulations and demonstrated ability to adequately interpret and implement quality standards considered an advantage.You have demonstrated the ability to manage more complex work and/or at parts of global projects.LocationsYou are local to Indianapolis, Penzberg, or Sant Cugat.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.Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our am

📌 Regulatory Affairs Manager (España)
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