Regulatory Affairs Project Manager
hace 2 semanas
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 As an International Regulatory Project Manager you will be a member of CDx International Cdx within the International Regulatory Chapter.In this position youwill focus on the support and delivery of high quality regulatory submissions of IVDs (including companion diagnostics) to Health Authorities worldwide. The Opportunity Products for the respective area of responsibility shall obtain Regulatory approvals in defined markets in close cooperation with other functions. The documents/deliverables for submissions are coordinated and compiled in a timely manner to support planned product registration timelines. The obtained Regulatory approvals/licenses products are maintained throughout the life cycle of the product by managing successful health authority notifications and submission, in accordance with quality management system change control processes. Ensure efficiency and success of Regulatory activities and strategies while collaborating closely with other functions, stakeholders and external partners (authorities, companies, NBs etc). Provide input to project and product regulatory strategy based on international regulatory requirements and support international regulatory submissions by provision of needed data and documents; answering Health Authority questions on the submissions; keeping our Affiliates informed about new products /projects/ process changes etc. The regulatory requirements and strategic aspects are understood, communicated and implemented, kept up to date and are transparent within the organization. Who you are Bachelor's / Master degree in Life Science, Data Science or related subject or equivalent experience (Completed training as a technician or laboratory technician; or equivalent qualification for the tasks) At least 5 years experience, 5-7 Years preferred, in Regulatory, R&D, Quality, Operations and/or Clinical Experience in diagnostics (highly preferred) preferred or pharmaceutical regulatory affairs. Advanced degree and experience in CDx is considered an advantage. Can manage high complexity work and/or global projects, or equivalent experience. Proven ability to work autonomously The target global grade for this position is between SE6 and SE7 . Ready to take the next step? We'd love to hear from you. Apply now to explore this exciting opportunity 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.
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Regulatory Affairs Graduate Intern
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Sant Cugat, Barcelona, España Roche A tiempo completoBei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst....
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Regulatory Affairs Specialist
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Sant Cugat, Barcelona, España GRIFOLS, S.A. A tiempo completotable.MiTabla { max-width: 1020px;important Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived...
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Regulatory Affairs Specialist
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Sant Cugat, Barcelona, España Grifols A tiempo completotable.MiTabla { max-width: 1020px;importantWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived...
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Energy Sourcing
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Sant Joan Despí, Barcelona provincia, España Essity A tiempo completo**Energy Sourcing & Regulatory Affairs Manager - Spain** **About the Role** This position supports the strategy for Energy procurement in Spain by sourcing energy for high-consumption sites within the framework of the global energy risk policy. You will manage regulatory issues related to energy consumption in Spain, ensuring compliance and...
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Sant Cugat del Vallès, España Grifols, S.A A tiempo completoA global healthcare company is seeking a Nucleic Acid Testing (NAT) Regulatory Affairs Specialist to join their Diagnostic Regulatory Affairs department. The candidate will prepare technical documentation, manage product registrations, and ensure compliance with regulations. Applicants should possess a Bachelor's in Health Sciences, experience in Regulatory...
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Técnico/a Regulatory Affairs
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Sant Llorenç d'Hortons, España AC Marca A tiempo completo¡En AC Marca seguimos creciendo! ¿Está considerando presentar su candidatura para este trabajo? Compruebe todos los detalles en esta descripción del puesto y luego haga clic en "Solicitar".Estamos buscando un/a Técnico/a Senior de Regulatory Affairs para que se una al equipo de nuestra planta en Sant Llorenç d'Hortons. Si tienes al menos 5 años de...
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Sant Cugat del Vallès, España Grifols, S.A A tiempo completoA global healthcare company in Sant Cugat del Vallès seeks a Regulatory Affairs Specialist Lab Automation to enhance regulatory compliance. This hybrid position requires a Bachelor's degree in a Life Sciences field and 2-5 years of regulatory experience, specifically with IVDR and FDA regulations. The role involves maintaining interfaces with regulatory...
