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Clinical Trial Regulatory Submission

Remote Full-time Pharmaceuticals & Biotech Associate

This is a Clinical Regulatory / Clinical Trial Submissions role.

The ideal candidate should have 4+ years in Pharma/CRO, with hands-on experience managing Clinical Trial Application (CTA) submissions, particularly EU CTR and ROW, while coordinating global cross-functional teams.

Core profile to target:

  • Clinical Trial Applications (CTA) / regulatory submissions
  • EU CTR submissions – is a MUST
  • ROW (Rest of World) submissions
  • End-to-end submission planning and project management
  • Clinical/regulatory documentation
  • Global/matrix stakeholder management
  • Submission timelines, tracking & KPIs
  • Risk, issue and dependency management
  • Quality investigations / compliance
  • Pharma / CRO / Clinical Research environment
  • Life Sciences / Pharmacy background
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