Regulatory & Start-Up Specialist — Site Activation

Precision For Medicine; Toowoomba Regional; Sur place; AUD 90 000 - 140 000; Plein temps

Résumé du poste

Precision for Medicine is a Clinical Research Organization seeking a Regulatory and Start Up Specialist in Australia to drive site activation readiness and regulatory submissions across assigned sites, ensuring timeliness and compliance.

The role requires a life sciences degree (or RN/Pharmacist), 1+ year in regulatory/start-up roles, and strong communication, organization, and English language skills. Experience with CA/EC submissions and start-up planning is preferred.

Qualifications

• Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline).
• A qualification in Pharmacy/work experience as a Pharmacist would be highly beneficial.
• 1 year or more as a Regulatory or SU specialist (or comparable role) in CRO/pharma/biotech industry or equivalent.

Responsabilités

• Delivery of site activation readiness within assigned country/sites to time and quality.
• Prepare Clinical Trial Application Forms and submission dossiers for authorities/ethics committees.
• Interact with CA/EC for study purposes and manage responses.
• Maintain project plans, trackers and regulatory intelligence tools.
• Prepare/start-up plans, IMP release requirements, and document criteria.

Connaissances

Regulatory submissions

Start-up planning

ICH-GCP knowledge

Documentation management

Cross-functional coordination

Formation

Bachelor's degree in life sciences or related field

Registered Nurse (RN) or Pharmacist qualification

Outils

eTMF

eCTD submission

Microsoft Excel

Description du poste

Precision for Medicine is a Clinical Research Organization seeking a Regulatory and Start Up Specialist in Australia to drive site activation readiness and regulatory submissions across assigned sites, ensuring timeliness and compliance.

The role requires a life sciences degree (or RN/Pharmacist), 1+ year in regulatory/start-up roles, and strong communication, organization, and English language skills. Experience with CA/EC submissions and start-up planning is preferred.