Remote Regulatory & Site Start-Up Specialist

Precision Medicine Group, LLC.; Australia; Remote; AUD 90,000 - 130,000; Full time

Job summary

Precision for Medicine is seeking a Regulatory and Site Start Up Specialist to lead regulatory submissions and site activation across assigned countries. You will manage CA/EC dossiers, IRB interactions, and essential document review, while partnering with sites and internal teams.

The ideal candidate has a life sciences degree with 1+ year in regulatory/start-up roles, strong communication skills, and fluency in English. Remote Australia work is supported, with global regulatory coordination.

Qualifications

• Bachelor's degree in life sciences or RN required.
• Fluency in English; local language where applicable.
• 1+ year in regulatory or site start-up in CRO/pharma.

Responsibilities

• Prepare and submit Clinical Trial Applications to CA/EC per local rules.
• Coordinate IRB/EC submissions and responses.
• Review and adapt Informed Consent Forms and ICFs.
• Maintain regulatory trackers and essential TMF documents.
• Support site start-up budgets and contract negotiations.
• Act as SME for country start-up timelines and requirements.

Skills

Strong communication skills

Organizational skills

Fluency in English

Education

Bachelor's degree in life sciences or RN

Advanced degree in medical or life sciences / RAC

Job description

Precision for Medicine is seeking a Regulatory and Site Start Up Specialist to lead regulatory submissions and site activation across assigned countries. You will manage CA/EC dossiers, IRB interactions, and essential document review, while partnering with sites and internal teams.

The ideal candidate has a life sciences degree with 1+ year in regulatory/start-up roles, strong communication skills, and fluency in English. Remote Australia work is supported, with global regulatory coordination.