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eTMF Specialist Regulatory Affairs

For our client, an innovative and dynamic bio-pharmaceutical company covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, we are looking for a eTMF Specialist Regulatory Affairs for a 24-month contract (with possibility of extension) based in Basel area, Switzerland.

The eTMF Specialist, Regulatory Affairs is responsible for the maintenance, quality, and inspection readiness of the electronic Trial Master File (eTMF) documents owned by Regulatory Affairs. The role ensures eTMF-relevant regulatory documentation is complete, accurate, timely, and compliant with applicable regulations and internal procedures. This position acts as the Regulatory Affairs subject matter expert for eTMF processes and supports submissions, inspections, and audits. The role works closely with Regulatory Affairs, third parties and Clinical Operations.

Main Responsibilities:

  • Maintain Regulatory Affairs content within the eTMF in accordance with regulatory requirements, ICH guidelines, and internal SOPs.
  • Liaise closely with third parties to obtain regulatory eTMF documents.
  • Prepare and perform ongoing quality control (QC) of regulatory eTMF documents for completeness, accuracy, version control, and metadata.
  • Ensure timely filing of regulatory documents in the eTMF, aligned with study timelines and milestones.
  • Support inspection and audit readiness by performing periodic eTMF reviews and remediation activities for regulatory content.
  • Act as the primary point of contact within Regulatory Affairs for eTMF‑related questions, issues, and process adherence.
  • Support eTMF reconciliation activities at study milestones and at study close‑out.
  • Collaborate with Clinical Operations, Quality Assurance, and IT to ensure consistency between Regulatory and Clinical eTMF practices.
  • Support internal and external audits and health authority inspections related to eTMF content.
  • Provide guidance and training to Regulatory Affairs staff and third parties on eTMF processes and expectations.

Qualifications and Experience:

  • Relevant working/residency permit or Swiss/EU-Citizenship required
  • Bachelor's degree or equivalent in Life sciences, pharmacy, regulatory science, or related discipline
  • Equivalent relevant experience in Regulatory Affairs operations or eTMF management may be considered in place of formal education
  • Min. 2 years’ experience in Regulatory Affairs, Regulatory Operations, or Clinical Trial Documentation
  • Min. 2 years’ experience in eTMF management using Veeva Vault Clinical
  • Advanced level in English
  • Experience working with third parties such as CROs
  • Ability to work independently
  • Initiative and attention to detail
  • Team spirit
  • Excellent organizational skills

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.

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