For our Client, one of the biggest Pharmaceutical Companies worldwide, we are looking for an Regulatory Affairs Specialist in Submission Archiving who will be responsible for maintaining regulatory information in a structured and secure environment to enable appropriate access, retrieval, and integrity. If you have relevant experience and would like to participate in the process, apply for this role.
what we offer
... - annual performance-based bonus
- opportunity to work with a leader in the pharmaceutical industry
- a 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
your tasks
- archives electronic submission documents and related communications in the official repository
- follows up with document providers to obtain missing items and to 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
what we expect
- 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
Employment agency entry number 47
this job offer is intended for people over 18 years of age