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Quality and Regulatory Documentation Specialist
7 dni temu
About the Company
Roche fosters diversity, equity and inclusion, representing the communities we serve. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we share a passion for exceptional care.
The Position
We're committed to finding better ways to prevent, diagnose, and monitor disease. As a Quality and Regulatory Documentation Administrator, you'll support regulatory submission processes and tender procedures in Poland and within export markets by ensuring the provision of necessary documentation.
Key Responsibilities
- Supporting registration and submission processes by providing required documentation.
- Utilizing regulatory documentation systems for navigation and documentation purposes.
- Communicating effectively with global teams and internal stakeholders.
- Monitoring change assessments and requests to ensure compliance with regulatory requirements and Roche policies.
- Supporting Affiliate Notification processes.
- Assisting in quality management activities and compliance audits.
- Supporting the Local Safety Officer (LSO) in case review activities.
- Performing additional activities as needed to support the team and project requirements.
Requirements
- Proven experience in administrative roles.
- Strong organizational skills and attention to detail.
- Excellent communication and interpersonal skills.
- Good command of English, both written and spoken.
- Ability to work collaboratively with global teams and internal stakeholders.
- Decision-making ability and independence in performing job duties.
