Regulatory Project Manager Diagnostics

at  Roche

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Position

• 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
• Creating, maintenance and approval of regulatory documentation for submissions and for ongoing activities related to compliance with Global Regulatory directives and regulations. (e.g stability reports, manufacturer workflows, compositions, etc…)
• Prepare change assessments and general surveys when required, collect answers, create specific reports to the Regulatory Affairs project teams
• Interfaces with internal stakeholders to collect data to prepare, maintain regulatory documentation
• Maintain documentation of the Regulatory Information Management System
• 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 on the preparation of educational materials/presentations
• Support on Regulatory process improvement activities