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Regulatory Affairs Manager

Regulatory Affairs Manager

Upsilon GlobalNone, Australia
3 days ago
Job description

Upsilon Global - Streamlining Clinical Trials

Upsilon Global are seeking a regulatory / start‑up lead in Australia to lead the launch of an early‑phase RSV vaccine trial.

Estimated at 0.5 FTE, this project is due to last 3 years and will include both phase I and phase II activities as part of a wider global trial.

The start‑up specialist will be responsible for key activities such as regulatory and ethics submissions, contract negotiations, IMP importation (from APAC) and sample exportation.

Key information :

Position : Freelance Regulatory Start‑up Lead

FTE :  0.5 fte

Start Date :  December 2025

Location :  Australia

  • Early phase experience
  • CTN & TGA submissions
  • Country specific documentation adaptation (eg ICF)
  • Import (IMP from China)
  • Export (labs to central lab - US) experience

Working closely with colleagues in Europe and the US, flexibility to attend early / late meetings will be required on occasion.

For more details, please apply via the link or contact

Seniority level

Not Applicable

Employment type

Contract

Job function

  • Research, Science, and Consulting
  • Hospitals and Health Care, Research Services, and Biotechnology Research
  • #J-18808-Ljbffr

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