Do you have an education in health-related or scientific discipline and a previous experience in Regulatory Affairs related to clinical trials environment ? Are you also fluent in English with the willingness to work in Brussels (hybrid work) as a Regulatory Affairs Administrator ? Then we may have your dream job!
Job Description
The Regulatory Affairs Administrator works under the hierarchical supervision of the Head of Regulatory Affairs Department (RAD).
Responsibilities
- You work under supervision and in close collaboration with the RA Manager
- You set the administrative frame for adequate filing and tracking of the RA Department responsibilities
- Set-up and maintains databases & tracking, for assigned trials
- You set the organizational structure of the new project in the available tracking, filing systems at the start of the study
- You ensure adequate administrative preparation & follow-up of clinical trial applications (CTAs) and relevant documents.
- You adapt CTA file to country specific and local requirements.
- You submit, follow-up and tracking of CTAs according to applicable national laws
- You verify regulatory documents received for validity and completeness
- You ensure appropriate follow-up of authorizations by filing approvals and related communication/ documents for amendments and notifications
- You contribute to the update of any country specific process documents (legal processes in countries, regulatory tools…)
- You ensure at any time compliance with procedures in changing legal environment
- You ensure the overall administrative support to the Regulatory Affairs Department
Requirements
- Bachelor's degree or experience in an administrative position
- Education in health-related or scientific discipline is an asset
- Experience in Regulatory Affairs related to clinical trials environment is an asset (CRO or university/ hospital or pharmaceutical industry)
- Demonstrated good organization, communication and time-management skills
- Eager to learn and demonstrate a high interest to investigate
- Collaborative spirit
- Excellent attention to detail and accuracy
- Proficient verbal and written English, any other language is an asset (especially Italian and/or German)
- Existing right to work in Europe required
Benefits
- Full-time position
- Competitive Salary Package
- 30 days holidays
- DKV hospitalization employer
- Free parking
- Full hybrid remote work
- Full reimbursement public transport
- Meal vouchers
- Pension plan
Vacancy number: 19214
