Regulatory Affairs Administrator

☞ EORTC

見る: 165

更新日: 16-11-2025

場所: Woluwe-Saint-Lambert Brussels Capital

カテゴリー: 経営管理 運輸/物流/倉庫

業界:

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仕事内容

Careers: Jobs: Regulatory Affairs Administrator

TheRegulatory 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
  • Ensures adequate administrative preparation & follow-up of clinical trial applications (CTAs) and relevant documents.
  • 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 employer
Free parking
Full hybrid
Full reimbursement public transport
Meal vouchers
Pension plan
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締切: 31-12-2025

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