Regulatory Affairs Specialist in Electronic Document Management
22 godzin temu
Randstad Polska Sp. z o.o. is seeking a highly skilled Regulatory Affairs Specialist in Electronic Document Management to join our team. As a key member of our team, you will be responsible for maintaining regulatory information in a secure environment to enable access, retrieval, and integrity.
Key Responsibilities:
- Archives electronic submission documents and related communications in the official repository
- Collaborates with document providers to obtain missing items and correct errors in the data
- Maintains and adheres to document management standards and templates
- Catalogs and classifies regulatory information documents into the content management system
- Provides support to the team in implementing new processes and practices
Requirements:
- Knowledge of Information Technology based business processes with project management or information/document management capabilities
- Fluency in English is a must
- Knowledge of Regulatory Affairs and Information Systems Planning tools
- Basic understanding of the drug development process
- Proficient in use of Microsoft Office software
- Basic knowledge of software development methodology, user acceptance testing practices and tools
What We Offer:
- Annual performance-based bonus
- Opportunity to work with a leader in the pharmaceutical industry
- Tangible impact on regulatory processes and the development of innovative products
- Hybrid work model (office in Warsaw)
- Additional leave benefits (e.g., bereavement leave) comprehensive medical care and life insurance
- Employer-sponsored retirement plan
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