An award-winning global full serviced Clinical Research Organisation with international reputation in providing Phase 1 to Phase IV clinical development services is looking for a Regulatory Submissions Coordinator.
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Responsibilities
Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials;
Prepare, review, and submit to Regulatory Agencies (TGA / Medsafe);
Communicate with global study teams and personnel on study progress;
Ability to effectively identify risks to site activations and mitigate as necessary;
Review and finalize essential documents required for site activation;
Act as a main contact for Ethical and Regulatory submission-related activities;
Direct contact with investigative sites during the study start up and activation process;
Ensure submissions comply with applicable regulations and guidance documents;
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Qualifications
Experience at a CRO, Pharmaceutical Company, or an investigative site;
Experience in preparing and submitting TGA regulatory applications;
Excellent organization and communication skills;
Knowledge of ICH - GCP guidelines and regulatory guidelines in Australia and New Zealand;
If you are interested, please apply with CV attached.
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