Regulatory Start-Up Specialist for Clinical Trials

Precision For Medicine; Queensland; Vor Ort; AUD 90.000 - 130.000; Vollzeit

Zusammenfassung

Precision Medicine Group is seeking a Regulatory and Start-Up Specialist to join our growing team. The role focuses on getting trials activated by preparing regulatory submissions, coordinating with authorities, and maintaining regulatory intelligence for assigned sites.

The ideal candidate will have life sciences education and experience in CRO or pharmaceutical settings, with strong English communication and organizational skills.

Qualifikationen

• Bachelor’s degree in life sciences or related field.
• 1 year or more as a Regulatory or Start-Up specialist in CRO or pharma.
• Fluency in English; strong communication and organizational skills.

Aufgaben

• Ensure timely site activation readiness for assigned country/sites.
• Prepare Clinical Trial Applications and submission dossiers for regulatory bodies.
• Coordinate with CA/EC and provide timely updates to study team.
• Maintain regulatory trackers and plans for start-up activities.
• Support budget negotiations and site contract processes as needed.

Kenntnisse

Communication skills

Organizational skills

English fluency

IT proficiency

Ausbildung

Bachelor’s degree in life sciences or related field

RN or Pharmacist qualification

Tools

MS Office (Word/Excel)

Jobbeschreibung

Precision Medicine Group is seeking a Regulatory and Start-Up Specialist to join our growing team. The role focuses on getting trials activated by preparing regulatory submissions, coordinating with authorities, and maintaining regulatory intelligence for assigned sites.

The ideal candidate will have life sciences education and experience in CRO or pharmaceutical settings, with strong English communication and organizational skills.