Global Regulatory & Site Start-Up Specialist

Precision For Medicine; Rockhampton Regional; On-site; AUD 70,000 - 120,000; Full time

Job summary

Precision for Medicine is seeking a Regulatory and Start Up Specialist to join our growing team in Australia. You will be responsible for timely and compliant activation of trial sites, preparing CTAs and submission dossiers, and coordinating with authorities, ethics committees, and internal teams to ensure on-time start-up.

The ideal candidate has a life sciences degree (RN or Pharmacy background beneficial) and 1+ year regulatory/start-up experience in CRO/pharma, with strong communication and

Qualifications

• Bachelor’s degree in life sciences or related field or RN or equivalent experience.
• Pharmacy/Pharmacist background is highly beneficial.
• 1+ year in regulatory or start-up role in CRO/pharma within regulations.

Responsibilities

• Deliver site activation readiness on time and with quality.
• Prepare Clinical Trial Applications and submission dossiers per local regulations.
• Interact with CA/EC and respond to submissions.
• Maintain regulatory trackers and start-up plans.
• Coordinate with site CRAs and other functions to ensure activation.

Skills

Communication skills

Organizational skills

English fluency

Education

Bachelor’s degree in life sciences or related field

RN (Registered Nurse) or Pharmacy degree beneficial

Advanced degree in regulatory science or RAC certification

Job description

Precision for Medicine is seeking a Regulatory and Start Up Specialist to join our growing team in Australia. You will be responsible for timely and compliant activation of trial sites, preparing CTAs and submission dossiers, and coordinating with authorities, ethics committees, and internal teams to ensure on-time start-up.

The ideal candidate has a life sciences degree (RN or Pharmacy background beneficial) and 1+ year regulatory/start-up experience in CRO/pharma, with strong communication and