In this role you drive regulatory activities for Roche’s Oncology In-vitro Diagnostics team, preparing global submissions and guiding dossiers through health authority processes. You collaborate with internal and external stakeholders to shape regulatory strategies and ensure compliant market access. You’ll apply agile methods to manage projects and continuously improve regulatory outcomes. This is an opportunity to impact patient access to innovative diagnostics while working in a diverse, inclusive environment. You help build strong partnerships and influence product direction with integrity and curiosity.
Responsabilidades
- Oversee development of registration dossiers for moderately complex products and manage global submission plans
- Lead external interface efforts, building relationships with stakeholders to influence regulatory direction
- Develop regulatory strategies aligned with frameworks like IVDR for simple-to-moderate complexity products
- Manage stakeholder relationships and communicate requirements and updates clearly
- Identify issues and propose solutions, driving innovation within the role
- Promote VAAC leadership principles and contribute to an inclusive, agile work environment
- Foster teamwork, share knowledge, and participate in conflict resolution
Requisitos principales
- Bachelor’s in Life Science (equivalent experience considered)
- 1+ years in Regulatory, R&D;, Quality and/or Clinical
- Experience in Healthcare Regulatory Affairs for IVD/Medical Device preferred
- Ability to manage high-complexity work and general projects
- collaboration
- stakeholder management
- clear communication
- regulatory submissions
- regulatory knowledge of IVDR
- project management