Remote Start-Up Specialist – EC & CA Submissions (Belgium)

Resourcing Life Science Ltd.; Belgique; À distance; EUR 40 000 - 60 000; Plein temps

Résumé du poste

Resourcing Life Science Ltd. in Belgium is seeking a Start up Specialist to support EC/CA submissions within a global CRO environment. This home-based role requires coordination of translations and ensuring study conduct aligns with GCP and ICH guidelines.

You will manage CA & EC submissions, stay current with regulatory requirements, and collaborate with cross-functional teams to deliver submission-ready documents across phase II–III studies. Fluency in English and Dutch or French is required.

Qualifications

• Bachelor degree in life-science required.
• Minimum 1.5 years in EC & CA submissions within CRO/Pharma/Biotech in Belgium.
• Experience in clinical studies phase II-III.

Responsabilités

• Responsible for CA & EC submission.
• Keep up to date knowledge of GCP and ICH Guidelines for clinical research.
• Translation and coordination of translations for documents required for submissions.
• Supervising study conduct according to GCP requirements and all applicable laws.

Connaissances

Fluent English

Dutch or French

Formation

Bachelor degree in life-science

Description du poste

Resourcing Life Science Ltd. in Belgium is seeking a Start up Specialist to support EC/CA submissions within a global CRO environment. This home-based role requires coordination of translations and ensuring study conduct aligns with GCP and ICH guidelines.

You will manage CA & EC submissions, stay current with regulatory requirements, and collaborate with cross-functional teams to deliver submission-ready documents across phase II–III studies. Fluency in English and Dutch or French is required.