Regulatory Affairs Support Coordinator (RASSU)

CTI Clinical Trial and Consulting Services; Lisboa; Presencial; EUR 18 000 - 24 000; Tempo integral

Resumo da oferta

CTI Clinical Trial and Consulting Services seeks a Regulatory Affairs Administrative Assistant to support document compilation and submissions for clinical trials in Lisbon. You will assist local study teams, ensure document quality in the study start‑up module and eTMF, and help manage tracking reports and translation workflows.

The role requires German and English language skills at C1, strong organizational ability, and the capacity to handle multiple tasks independently while using Microsoft

Qualificações

• 1 year of research or regulatory experience.
• Sound basic knowledge of medical and pharmaceutical terminology.
• Understanding of the drug development and clinical trial process.
• Experience using Microsoft tools to edit, reformat, and finalize regulatory documents.
• Bachelor’s Degree in allied health fields such as nursing, pharmacy, or health/natural science.

Responsabilidades

• Assist in compilation and revision of RA documents for clinical trials submissions.
• Assist with contact to local study teams for RA documents collection and checks.
• Assist in obtaining maintenance documents from sites during the trial.
• Assist in quality checks of documents in the study start‑up module and eTMF.
• Assist in SUSARs submission package preparation to ethics committees where applicable.
• Provide backup support for RA activities and trainings as needed.
• Attend weekly team meetings and assist in preparing agendas and minutes.

Conhecimentos

German (C1)

English (C1)

Excellent communication

Organizational skills

Independent worker

Multitasking

Computer skills

Microsoft Office

Formação académica

Bachelor's degree in allied health fields such as nursing, pharmacy, or health/natural science

Ferramentas

Microsoft Office

Descrição da oferta de emprego

CTI Clinical Trial and Consulting Services seeks a Regulatory Affairs Administrative Assistant to support document compilation and submissions for clinical trials in Lisbon. You will assist local study teams, ensure document quality in the study start‑up module and eTMF, and help manage tracking reports and translation workflows.

The role requires German and English language skills at C1, strong organizational ability, and the capacity to handle multiple tasks independently while using Microsoft