Regulatory Affairs Project Manager
vor 2 Wochen
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 Project Manager
vor 2 Wochen
Rotkreuz, Zug, Schweiz Roche Vollzeit CHF 90'000 - CHF 120'000 pro JahrJOB DESCRIPTION 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...
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Regulatory Affairs Project Manager
vor 2 Wochen
Rotkreuz, Zug, Schweiz Roche Vollzeit CHF 80'000 - CHF 100'000 pro JahrAt 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...
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Sr Associate Clinical Trials Regulatory Affairs
Vor 2 Tagen
Rotkreuz, Schweiz Amgen VollzeitIf you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that read over 10...
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Regulatory Affairs Associate — Global Compliance
vor 3 Wochen
Rotkreuz, Schweiz Sandoz VollzeitA leading global pharmaceutical company in Zug, Switzerland seeks a Regulatory Affairs Associate to support regulatory activities, compliance tasks, and administrative support. Ideal candidates will have a Bachelor's degree in life sciences, experience in a regulated environment, and proficiency in German and English. The role offers a hybrid work model and...
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Regulatory Affairs Support Intern
vor 2 Wochen
Rotkreuz, Zug, Schweiz Opella Vollzeit CHF 40'000 - CHF 60'000 pro JahrOpella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.Our mission: to bring health in people's hands by making self-care as simple as it should be for over half a billion consumers worldwide.At the core of this mission is our 100+ loved brands, our...
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Regulatory Affairs Support Intern
vor 2 Wochen
Rotkreuz, Zug, Schweiz Opella Vollzeit CHF 40'000 - CHF 60'000 pro JahrOpella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.Our mission: to bring health in people's hands by making self-care as simple as it should be for over half a billion consumers worldwide.At the core of this mission is our 100+ loved brands, our...
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Regulatory Affairs Managers
Vor 2 Tagen
Rotkreuz, Schweiz Amgen VollzeitCareer Category Regulatory **Job Description**: HOW MIGHT YOU DEFY IMAGINATION? - If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve...
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Regulatory Affairs Associate
vor 3 Wochen
Rotkreuz, Schweiz Sandoz VollzeitRegulatory Affairs Associate (d/f/m) 80 – 100% Join to apply for the Regulatory Affairs Associate (d/f/m) 80 – 100% role at Sandoz Job Description Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path,...
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Regulatory Affairs Associate
vor 6 Stunden
Rotkreuz, Zug, Schweiz Sandoz VollzeitSandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shapeThe Country Regulatory Affairs...
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Project Manager
vor 2 Wochen
Rotkreuz, Schweiz We make it GmbH VollzeitWe make it GmbH is a company operating nationally in Switzerland which, thanks to many years of successful experience, has a high level of competence in the personnel services sector. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH places the highest...
