Empregos actuais relacionados com Regulatory Affairs Project Manager - Amadora, Lisboa - Roche
-
Project Manager
2 semanas atrás
Amadora, Lisboa, Portugal Siemens Tempo inteiroJob ID487488Posted since03-Dec-2025OrganizationGlobal Business ServicesField of workInformation TechnologyCompanySiemens S.A.Experience levelExperienced ProfessionalJob typeFull-timeWork modeHybrid (Remote/Office)Employment typePermanentLocation(s)Amadora - Lisboa - PortugalSiemens Global Business Services (GBS) enables Siemens units worldwide and external...
-
Junior Application Manager
2 semanas atrás
Amadora, Lisboa, Portugal TÜV Rheinland Group Tempo inteiroThe TÜV Rheinland Group, as a sustainable and independent provider of testing, inspection, certification, consulting and training, has been a world leader in quality and safety assurance for more than 150 years, with more than 24,000 employees.Are you passionate about shaping digital solutions that empower business operations worldwide? We are looking for...
-
Practice Lead
1 semana atrás
Amadora, Lisboa, Portugal Nokia Tempo inteiroJob DescriptionThe Practice Lead - Architecture at Nokia is responsible for enhancing the design, deployment, and testing processes within the S&C Services and Care domain for Core networks and Business applications. This role focuses on developing Standard Operating Procedures in collaboration with subject matter experts, managing technical stakeholder...
-
Financial Analyst(m/f/d)
Há 14 horas
Amadora, Lisboa, Portugal Siemens Tempo inteiroWe are a company for what the world needs, today and in the futureWe develop technology for industries, infrastructure, transport, and healthcare, bridging the gap between the real and digital worlds. This empowers our customers to revolutionize their industries and markets, enhancing their competitiveness, resilience, and sustainability. For 176 years,...
-
Product Owner
Há 13 horas
Amadora, Lisboa, Portugal Siemens Tempo inteiroJob ID490140Posted since08-Jan-2026OrganizationMobilityField of workResearch & DevelopmentCompanySIEMENS MOBILITY, UNIPESSOAL LDAExperience levelExperienced ProfessionalJob typeFull-timeWork modeHybrid (Remote/Office)Employment typeFlexibleLocation(s)Amadora - Lisboa - PortugalSiemens Mobility Portugal is a leading provider of innovative mobility products...
-
Product Owner – Automation
Há 13 horas
Amadora, Lisboa, Portugal Siemens Tempo inteiroJob ID488913Posted since16-Dec-2025OrganizationSmart InfrastructureField of workResearch & DevelopmentCompanySiemens S.A.Experience levelExperienced ProfessionalJob typeFull-timeWork modeOffice/Site onlyEmployment typePermanentLocation(s)Amadora - Lisboa - PortugalSiemens Smart Infrastructure intelligently connects energy systems, buildings and industries....
-
Procurement Support Trainee
1 semana atrás
Amadora, Lisboa, Portugal Nokia Tempo inteiroJob DescriptionCloud and Network Services: As Nokia's growth engine, we create value for communication service providers and enterprise customers by leading the transition to cloud-native software and as-a-service delivery models. Our inclusive team of dreamers, doers and disruptors push the limits from impossible to possible.This is a Professional...
-
VAT Tax Trainee
1 semana atrás
Amadora, Lisboa, Portugal Siemens Tempo inteiroJob ID488350Posted since11-Dec-2025OrganizationGlobal Business ServicesField of workInternal ServicesCompanySiemens S.A.Experience levelRecent College GraduateJob typeFull-timeWork modeHybrid (Remote/Office)Employment typeFixed TermLocation(s)Amadora - Lisboa - PortugalSiemens Global Business Services (GBS) enables Siemens units worldwide and external...
-
Communication & Visual Content Trainee (IoT Product Management)
2 semanas atrás
Amadora, Lisboa, Portugal Siemens Tempo inteiroJob ID486349Posted since04-Dec-2025OrganizationSmart InfrastructureField of workInternal ServicesCompanySiemens S.A.Experience levelRecent College GraduateJob typeFull-timeWork modeHybrid (Remote/Office)Employment typeFixed TermLocation(s)Amadora - Lisboa - PortugalCreate a better #TomorrowWithUsAt Siemens, we build technology solutions to shape the world we...
-
Data Product Owner
Há 14 horas
Amadora, Lisboa, Portugal Siemens Tempo inteiroJob ID489214Posted since17-Dec-2025OrganizationSmart InfrastructureField of workResearch & DevelopmentCompanySiemens S.A.Experience levelExperienced ProfessionalJob typeFull-timeWork modeOffice/Site onlyEmployment typePermanentLocation(s)Amadora - Lisboa - PortugalPorto - Porto - PortugalCreate a better #TomorrowWithUsAt Siemens, we build technology...
Regulatory Affairs Project Manager
2 semanas atrás
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 PositionAs 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 areA 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.
