REGULATORY AFFAIRS ADMINISTRATOR
Main responsibilities / Major activities
Including but not limited to:
- Sets the administrative frame for adequate filing and tracking of the Regulatory Affairs responsibilities.
- Set-up and maintains Regulatory Affairs (RA) database & tracking
- Ensures adequate administrative preparation & follow-up of clinical trial applications (CTAs) and relevant documents in the countries allocated.
- Sets the organizational structure of the new project in the available tracking, filing systems at the start of the study
- Adapts master cover/submission letters to CA(s), EC(s), and Principal Investigators (PIs) from master study documents to local requirements.
- Adapts/submits country specific xml files following master XML prepared by RAM and processes with submission and tracking of approvals on allocated countries
- Ensures appropriate follow-up of authorizations by filing approvals and related communication/ documents for amendments and declaring the EoR/ EoT
Career opportunities evolve in view of the individual skills of the employee.
- Minimum Bachelor Degree / Graduate (level A1) in administration or science oriented courses
- Experience in Regulatory Affairs related to clinical trials environment required (CRO or university/ hospital or pharmaceutical industry)
- Proficient in Word, Excel & PowerPoint, skills in SharePoint are an asset
- Ability to cope with and meet tight timelines when required
- Able to manage multiple tasks at the same time
- Able to work independently as well as part of a team
- Demonstrated good organization, communication and time-management skills
- Excellent attention to detail and accuracy
- Proficient verbal and written English, other Member State language is an asset