Regulatory Affairs Project Manager
hace 6 días
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.
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