Global Regulatory & Site Start-Up Expert

Precision Medicine Group; Australia; Remote; AUD 90.000 - 120.000; Vollzeit

Zusammenfassung

Precision Medicine Group seeks a Regulatory and Site Start Up Specialist in Australia to manage regulatory submissions and site activation activities across assigned sites. You will prepare CTAs and dossiers for competent authorities and ethics committees, maintain essential documents, and collaborate with CRAs to ensure timely site activation.

You will support feasibility, budgeting, and guidance to in-country teams while staying compliant with local and international regulations.

Qualifikationen

• Bachelor’s degree in life sciences or RN or equivalent combination of education, training and experience.
• 1 year or more regulatory or start-up experience in CRO/pharma/biotech or equivalent.
• Strong communication and organizational skills essential.
• Fluency in English; local language of country if non-English speaking.
• Experience with computerized information systems, spreadsheets, word processing and email.

Aufgaben

• Deliver site activation readiness within assigned country/sites, ensuring timeliness and quality.
• Prepare Clinical Trial Applications and submission dossiers for Authority and Ethics Committees.
• Interact with regulatory authorities and EC/IRB; provide updates to Study Team.
• Maintain regulatory trackers, plans and tools; support start-up activities.
• Coordinate with site CRAs to ensure site collaboration and timely document collection.

Kenntnisse

Regulatory start-up

Clinical trials

Project coordination

Communication skills

English fluency

Ausbildung

Bachelor’s degree in life sciences

RN (Registered Nurse)

Tools

MS Office

Electronic data systems

Jobbeschreibung

Precision Medicine Group seeks a Regulatory and Site Start Up Specialist in Australia to manage regulatory submissions and site activation activities across assigned sites. You will prepare CTAs and dossiers for competent authorities and ethics committees, maintain essential documents, and collaborate with CRAs to ensure timely site activation.

You will support feasibility, budgeting, and guidance to in-country teams while staying compliant with local and international regulations.