Specialist

En Roche puedes ser tú mismo y sentirte valorado por tus cualidades únicas. Nuestra cultura fomenta la expresión personal, el diálogo abierto y las conexiones genuinas, donde eres valorado, aceptado y respetado por lo que eres, permitiéndote prosperar tanto de manera personal como profesionalmente. Así es como buscamos prevenir, detener y curar enfermedades y asegurarnos de que todos tengan acceso a la atención sanitaria hoy y para las futuras generaciones. Únete a Roche, donde cada voz importa. La posición 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. Quienes somos Alcanzar un futuro más saludable es lo que nos impulsa a innovar. Juntos, más de 100.000 empleados en todo el mundo están dedicados a avanzar en la ciencia, asegurando que todos tengan acceso a la atención sanitaria hoy y para las futuras generaciones. Nuestros esfuerzos resultan en más de 26 millones de personas tratadas con nuestros medicamentos y más de 30 mil millones de pruebas realizadas con nuestros productos de Diagnósticos. Nos damos apoyo mutuamente para explorar nuevas posibilidades, fomentar la creatividad y mantener altas nuestras ambiciones, para poder ofrecer soluciones sanitarias que cambian la vida e impactan a nivel global. Construyamos juntos un futuro más saludable. Roche es una empresa que ofrece igualdad de oportunidades.