Regulatory Specialist Diagnostics - Fixed term (6 months)

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 Opportunity:

As a Regulatory Specialist you will be responsible to compile documents and deliverables to support planned product registration timelines. You will maintain product registration throughout a product’s lifecycle by applying successful regulatory change control. You will maintain clear agreement with other functions, stakeholders, and external partners (such as health authorities, companies, and notified bodies) to promote success of the registration activities and strategies. Collaborates with other functions in the organization to obtain regulatory approvals for products with defined markets.  

Please note that this is a fixed-term position for a duration of 6 months.

• Compile essential regulatory documentation for multiple products within a dedicated project, ensuring the continued compliance of our on-market portfolio and maintaining our license to operate. This position involves collaboration with diverse stakeholders and managing the end-to-end lifecycle of a specific regulatory document; from creation to final release into our document management system.
• Provides support to currently marketed products, e.g., labeling, product and manufacturing changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to regulatory requirements. This includes annual reporting and laser reporting in relevant countries.
• Interfaces with internal stakeholders to collect data to prepare, maintain regulatory documentation. This includes internal documentation decisions and review of analytical data report review and authoring of relevant analytical documentation.
• Maintain documentation of the Regulatory Information Management System and create and maintain product information on the Regulatory Information Management System
• Create reports on Regulatory Information Management System
• Responsible for maintenance of product technical files and for ongoing activities related to compliance with Global Regulatory directives and regulations
• Support for documentation management system workflows and support for any appropriate submission activity

Who you are:

• Bachelor's/Master's degrees or equivalent experience
• 0-3 years experience, in Regulatory, R&D, Quality, Operations and/or Clinical. Fresh graduates are also welcome.
• Equivalent experience may be satisfied by having completed training as a technician, a laboratory technician, or an equivalent qualification
• Fluent in English, additional languages (German or French or Latvian or Polish or Slovene or Turkish) is a plus
  
• Proven ability to work autonomously 

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.