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eTMF Specialist Regulatory Affairs

Company

CTC

Location

basel, basel city

Type

Full-time

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 an...

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