Global Regulatory & Site Start-Up Specialist

Precision Medicine Group; Sydney; On-site; AUD 90,000 - 120,000; Full time

Job summary

Precision Medicine Group is seeking a Regulatory and Site Start Up Specialist to drive regulatory submissions, start-up activities, and site activation in Australia. The role partners with CA/EC, IRBs, and internal teams to ensure on-time approvals and compliant TMF documentation.

You must have a life sciences degree, 1+ year of regulatory/start-up experience, and strong English communication. The team values rigorous processes, cross-functional collaboration, and proactive risk management for

Qualifications

• Bachelor's degree in life sciences or RN or equivalent.
• 1 year or more in regulatory or site start-up in CRO or pharma.
• Strong English communication and organizational skills.
• Experience with regulatory submissions and TMF/documents.

Responsibilities

• Deliver timely, high-quality site activation readiness for assigned sites.
• Prepare Clinical Trial Applications and submission dossiers for CA/EC.
• Coordinate with CA/EC, IRB/Ethics Committees and internal teams.
• Maintain regulatory trackers, start-up plans and essential documents.
• Support budget negotiations and country-specific tool development as SME.

Skills

Regulatory experience

Site start-up

Regulatory submissions

Communication skills

Organizational skills

Education

Bachelor's degree in life sciences

RN or related field

Tools

MS Excel

TMF systems

Word processing

Email systems

Job description

Precision Medicine Group is seeking a Regulatory and Site Start Up Specialist to drive regulatory submissions, start-up activities, and site activation in Australia. The role partners with CA/EC, IRBs, and internal teams to ensure on-time approvals and compliant TMF documentation.

You must have a life sciences degree, 1+ year of regulatory/start-up experience, and strong English communication. The team values rigorous processes, cross-functional collaboration, and proactive risk management for