Regulatory Affairs Specialist

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. The Position 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. As a Regulatory Affairs Specialist you will have the opportunity to work with internal and external teams for project/product realization, write and prepare submission packets for health authority marketing approvals, and utilize agile principles to drive regulatory activities for our Oncology In-vitro Diagnostics (IVD) team. Your Opportunity Regulatory document and submission compilation: You oversee the development of registration dossiers for moderately complex products or programs. You develop and manage comprehensive global regulatory submissions and registration plans. External interface management: You take initiative and partner effectively with stakeholders to understand problems and opportunities to provide best solutions. This includes developing external relationships that significantly influence the present and future direction for Roche and our products. You contribute to audit preparation, execution and follow up. Regulatory knowledge and strategy: You develop a good understanding of healthcare regulatory frameworks, such as IVDR. You apply this understanding to create a regulatory strategy to legally market Roche products and programs of simple-to-moderate regulatory complexity. Stakeholder management and influencing: You understand the organizational relationships, key roles, needs, and responsibilities of stakeholders and apply effective stakeholder management. You build effective and enduring relationships with stakeholders and communicate timely and effectively. Decision making/Innovation and problem solving: You work with minimal supervision to correctly complete daily activities, which includes presenting both issues and solutions. You drive innovation within one’s own area of influence, and generate consistently new ideas. This includes leveraging unique talents and viewpoints of others. VAAC Leadership and agility: You develop the skill to live the spirit of “we all lead” and identify opportunities to develop VACC competency. You act with integrity, courage, passion, and honors commitments. This includes contributing to an inclusive environment which supports all dimensions of diversity and are open-minded to new technology/other means to increase productivity. Teamwork and communication: You establish strong collaborative relationships, share information, knowledge, and guidance readily.You recognize potential conflicts and actively participate in conflict resolution. You are open to the input of others and are truthful regardless of the circumstances. Who You Are You have a Bachelor’s or Master's degree in Life Science, Data Science or related subject. Equivalent experience will be considered. You have 1+ years experience, in Regulatory, R&D, Quality and/or Clinical You have experience in Healthcare Regulatory Affairs for IVD/Medical Device preferred. You can manage high complexity work and/or global projects, or equivalent experience. Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. 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 ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.