Regulatory & Site Activation Expert

Precision for Medicine; Sydney; On-site; AUD 90,000 - 140,000; Full time

Job summary

Precision for Medicine seeks a Regulatory and Site Start Up Specialist to lead regulatory activities for clinical trials. You will manage initial and follow-up submissions to Competent Authorities and IRBs, review informed consent forms, and support site contracts and budget negotiations.

Strong regulatory knowledge and site start-up experience are essential. The role involves coordinating with cross-functional teams to ensure on-time site activation, maintaining essential documents, and

Qualifications

• Bachelor’s degree in life sciences or RN or equivalent.
• 1 year+ regulatory or site start-up experience in CRO/pharma or equivalent.
• Strong communication and organizational skills.
• Experience with regulatory submissions to CA/EC/IRB/EC
• Fluency in English (and local language as applicable).

Responsibilities

• Deliver timely and high-quality site activation readiness for assigned sites/countries.
• Prepare Clinical Trial Applications and submission dossiers for CA/EC/IRB/EC.
• Interact with regulatory bodies and respond to agency inquiries.
• Provide regular updates to Start Up Lead/Regulatory Lead and Project Team.
• Maintain regulatory trackers and intelligence tools for assigned responsibilities.

Skills

Communication skills

Organizational skills

English proficiency

Education

Bachelor’s degree in life sciences

RN or equivalent qualification

Job description

Precision for Medicine seeks a Regulatory and Site Start Up Specialist to lead regulatory activities for clinical trials. You will manage initial and follow-up submissions to Competent Authorities and IRBs, review informed consent forms, and support site contracts and budget negotiations.

Strong regulatory knowledge and site start-up experience are essential. The role involves coordinating with cross-functional teams to ensure on-time site activation, maintaining essential documents, and