Main Responsibilities:
1. Maintain Regulatory Affairs content within the eTMF in accordance with regulatory requirements, ICH guidelines, and internal SOPs.
2. Liaise closely with third parties to obtain regulatory eTMF documents.
3. Prepare and perform ongoing quality control (QC) of regulatory eTMF documents for completeness, accuracy, version control, and metadata.
4. Ensure timely filing of regulatory documents in the eTMF, aligned with study timelines and milestones.
5. Support inspection and audit readiness by performing periodic eTMF reviews and remediation activities for regulatory content.
6. Act as the primary point of contact within Regulatory Affairs for eTMF‑related questions, issues, and process adherence.
7. Support eTMF reconciliation activities at study milestones and at study close‑out.
8. Collaborate with Clinical Operations, Quality Assurance, and IT to ensure consistency between Regulatory and Clinical eTMF practices.
9. Support internal and external audits and health authority inspections related to eTMF content.
10. Provide guidance and training to Regulatory Affairs staff and third parties on eTMF processes and expectations.
Qualifications and Experience:
11. Relevant working/residency permit or Swiss/EU-Citizenship required
12. Bachelor's degree or equivalent in Life sciences, pharmacy, regulatory science, or related discipline
13. Equivalent relevant experience in Regulatory Affairs operations or eTMF management may be considered in place of formal education
14. Min. 2 years’ experience in Regulatory Affairs, Regulatory Operations, or Clinical Trial Documentation
15. Min. 2 years’ experience in eTMF management using Veeva Vault Clinical
16. Advanced level in English
17. Experience working with third parties such as CROs
18. Ability to work independently
19. Initiative and attention to detail
20. Team spirit
21. Excellent organizational skills