Remote Regulatory Start-Up Lead for ANZ Trials

Sironax Ltd.; Australia; Remote; AUD 130,000 - 180,000; Full time

Job summary

Sironax Ltd. is seeking a Regulatory Start-Up Manager to lead study activation across Australia and New Zealand. Remote work within Australia is available. You will coordinate regulatory, ethics, contracting, and operational start-up activities to ensure compliant and timely site activation.

The role requires deep knowledge of ICH-GCP and local regulations, strong cross‑functional collaboration, and experience with CTN/CTA and HREC processes. Oncology and early-phase trials are advantageous.

Qualifications

• Experience in regulatory and start-up functions for clinical trials.
• Knowledge of CTN/CTA submissions and ethics submissions.
• Familiarity with Australian and NZ regulations (TGA, HREC, ANZCTR).

Responsibilities

• Lead and coordinate study start-up activities from protocol finalisation to site activation.
• Prepare, submit, and track CTN/CTA and regulatory documentation.
• Manage HREC submissions, amendments, annual reports, and safety reports.
• Coordinate SSA, RGO, and governance submissions for AU sites.
• Support Medsafe notifications and HDEC submissions for NZ trials.
• Maintain ANZCTR registrations and study document trackers.

Skills

Regulatory affairs

Project coordination

Stakeholder management

Documentation management

Microsoft Office

Education

Bachelor’s degree in Life Sciences

Tools

CTMS

eTMF

Job description

Sironax Ltd. is seeking a Regulatory Start-Up Manager to lead study activation across Australia and New Zealand. Remote work within Australia is available. You will coordinate regulatory, ethics, contracting, and operational start-up activities to ensure compliant and timely site activation.

The role requires deep knowledge of ICH-GCP and local regulations, strong cross‑functional collaboration, and experience with CTN/CTA and HREC processes. Oncology and early-phase trials are advantageous.