Regulatory Affairs Administrator
il y a 2 jours
The Regulatory Affairs Administrator works under the hierarchical supervision of the Head of Regulatory Affairs Department (RAD).
**Main responsibilities / Major Activities**:
- Works under supervision and in close collaboration with the RAM
- Sets the administrative frame for adequate filing and tracking of the RAD responsibilities
- Set-up and maintains databases & tracking, for assigned trials
- Sets the organizational structure of the new project in the available tracking, filing systems at the start of the study
- Adapts CTA file to country specific and local requirements.
- Submit, follow-up and tracking of CTAs according to applicable national laws
- Verifies regulatory documents received for validity and completeness
- Ensures appropriate follow-up of authorizations by filing approvals and related communication/ documents for amendments and notifications
- Contributes to the update of any country specific process documents (legal processes in countries, regulatory tools )
- Ensure at any time compliance with EORTC procedures in changing legal environment
- Overall administrative support to the Regulatory Affairs Department
**Profile**:
- Bachelor’s or Master’s degree in a health-related or scientific discipline
- 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)
**Benefits**:
- 30 days holidays- Competitive Salary Package- DKV Hospitalization insurance- Free parking- Full reimbursement public transport- Hybrid working environment- Meal vouchers- Pension plan- Permanent contract- Homeworking allowance
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