Freelancer QPPV​/FVP

For an upcoming project, we are looking for an experienced QPPV / FVP Freelancer with strong knowledge of the Swiss regulatory and pharmacovigilance environment.

The project involves two products planned for national Marketing Authorisation Applications with Swiss medic
, based on existing eCTD dossiers currently undergoing EU Decentralised Procedures (DCP).

• Gap Analysis: Review of the available eCTD dossiers and assessment of Swiss-specific requirements
• Advice on the appropriate Swiss regulatory pathway
• Preparation of the Swiss-specific dossier
  , including Module 1
• Compilation and submission of the Swiss medic applications
• Preparation and coordination of responses to Swiss medic during the review
• Regulatory correspondence with Swiss medic until approval
• Regulatory support through completion of the initial Marketing Authorisation procedure

• Proven experience as QPPV / FVP in Switzerland
• Strong hands‑on knowledge of Swiss medic requirements and submission processes
• Experience with eCTD dossiers and national Marketing Authorisation Applications
• Ability to independently manage and coordinate the regulatory activities throughout the submission and review process

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