Regulatory Affairs Manager
Roche · Indianapolis, Indiana, United States
About this role
<p style="text-align:left"><span>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.</span></p><h3></h3><p></p><h3>The Position</h3><p><span>A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come
Creating a world where we all have more time with the people we love. That’s what makes us Roche. </span></p><p></p><p><span>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 systems and software including hardware-software instrument systems. This role will specifically support our Sequencing portfolio in our Molecular Customer Area. You can expect an open-minded work environment, where you will be working closely with colleagues in other departments and other counties.</span><br /> </p><p><b><span>The Opportunity</span></b></p><ul><li><p><span>You oversee regulatory document and submission compilation, which includes the development of submission/product registration dossiers of more complex products/programs
You develop and manage parts of comprehensive global regulatory submissions and registration plans. Specifically, you bring knowledge of USFDA regulations including Research Use Only (RUO) and IVD marketing pathways.</span></p></li><li><p><span>You interface with external management. You understand the structure, key roles and responsi
Apply for this role on Roche’s official careers site.