Global Regulatory & Site Start-Up Specialist

Precision For Medicine; Bathurst; On-site; AUD 90,000 - 130,000; Full time

Job summary

Precision for Medicine is seeking a Regulatory and Start-Up Specialist to ensure timely site activation readiness across assigned countries/sites. You will prepare CTAs and submission dossiers for authorities and ethics committees, maintain regulatory trackers, and collaborate with site CRAs and cross-functional teams to meet study timelines.

The ideal candidate has a life sciences degree (RN or Pharmacist beneficial) and 1+ year in regulatory/start-up within CRO or pharmaceutical environments,

Qualifications

• Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline).
• Registered Nurse (RN) or Pharmacist qualification would be beneficial.
• 1 year or more as a Regulatory or Start-Up specialist (or comparable role) in CRO or pharma industry.

Responsibilities

• Deliver site activation readiness on time and ensure regulatory submissions meet timelines.
• Prepare Clinical Trial Applications and submission dossiers for Competent Authorities and Ethics Committees.
• Maintain project plans, trackers and regulatory intelligence tools for assigned responsibilities.
• Coordinate with site CRAs to ensure alignment and secure site activation.
• Translate/coordinate translations of key regulatory documents as needed.
• Communicate with Regulatory Lead, Start-Up Lead, and Project Team on status and deliverables.

Skills

Regulatory submissions

Documentation management

Fluency in English

Communication skills

Education

Bachelor’s degree in life sciences

RN

Pharmacist qualification

Job description

Precision for Medicine is seeking a Regulatory and Start-Up Specialist to ensure timely site activation readiness across assigned countries/sites. You will prepare CTAs and submission dossiers for authorities and ethics committees, maintain regulatory trackers, and collaborate with site CRAs and cross-functional teams to meet study timelines.

The ideal candidate has a life sciences degree (RN or Pharmacist beneficial) and 1+ year in regulatory/start-up within CRO or pharmaceutical environments,