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.
- 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;
- 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.