Global Regulatory & Site Start-Up Specialist

Precision Medicine Group; Sydney; Presencial; AUD 90 000 - 150 000; Tempo integral

Resumo da oferta

Precision Medicine Group, a leading life sciences CRO, is seeking a Regulatory and Site Start Up Specialist to drive regulatory submissions and site activation across assigned sites. The role requires coordination with CA/EC, IRB/EC submissions, and essential document management to ensure on-time activation.

The RSS will support budget reviews, translation coordination, and cross-functional collaboration with Feasibility, Clinical Operations, and Site Contracts teams to ensure regulatory

Qualificações

• Bachelor’s degree in life sciences or RN or equivalent.
• 1+ year as Regulatory or Site Start-Up specialist in CRO/pharma.
• Strong communication and organizational skills are essential.
• Fluency in English; local language proficiency if required.

Responsabilidades

• Ensure timely site activation readiness for assigned countries/sites.
• Prepare Clinical Trial Applications and submission dossiers for CA/EC.
• Interact with CA/EC and respond to regulatory requests.
• Provide updates on submissions to Start Up Lead and Project Team.
• Maintain regulatory trackers, TMF readiness and intelligence tools.
• Support start-up plans, IMP release requirements and essential document review.
• Collaborate with site CRA to align communication and site collaboration.
• Prepare and manage collection of essential activation documents.
• Translate/coordinate translations for submission documents.
• Maintain cross-functional communication with Feasibility, Ops, PM, Regulatory and Site Contracts.

Conhecimentos

Communication skills

Organizational skills

English fluency

Formação académica

Bachelor's degree in life sciences

RN or equivalent

Advanced degree in life sciences / RAC / regulatory science

Descrição da oferta de emprego

Precision Medicine Group, a leading life sciences CRO, is seeking a Regulatory and Site Start Up Specialist to drive regulatory submissions and site activation across assigned sites. The role requires coordination with CA/EC, IRB/EC submissions, and essential document management to ensure on-time activation.

The RSS will support budget reviews, translation coordination, and cross-functional collaboration with Feasibility, Clinical Operations, and Site Contracts teams to ensure regulatory