- You set the administrative frame for adequate filing and tracking of the Regulatory Affairs responsibilities.
- You set-up and maintain Regulatory Affairs (RA) database & tracking
- You ensure adequate administrative preparation & follow-up of clinical trial applications (CTAs) and relevant documents in the countries allocated.
- You set the organizational structure of the new project in the available tracking, filing systems at the start of the study
- You adapt master cover/submission letters to CA(s), EC(s), and Principal Investigators (PIs) from master study documents to local requirements.
- You adapt/submit country specific xml files following master XML prepared by RAM and processes with submission and tracking of approvals on allocated countries
- You ensure 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.
- You have a University degree in administration or science oriented courses
- You have a first experience as a CTA with experience in supporting start-up tasks or you have a first experience in Regulatory Affairs related to clinical trials environment required (CRO or university/ hospital or pharmaceutical industry)
- You are proficient in Word, Excel & PowerPoint, skills in SharePoint are an asset
- You have the ability to cope with and meet tight timelines when required
- You are able to manage multiple tasks at the same time
- You are able to work independently as well as part of a team
- You demonstrate good organization, communication and time-management skills
- You pay an excellent attention to detail and accuracy
- You are fluent in English