Job Description
We are currently seeking a full‐time, office‐based Entry Level Regulatory Submissions Coordinator to join our Clinical Operations team in Melbourne, Australia. This role is a vital part of the team, responsible for ensuring timely and compliant regulatory submissions to support the start‐up and activation of investigative sites throughout all phases of clinical trials.
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Responsibilities
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Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials.
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Prepare, review, and submit regulatory documents to agencies such as TGA and Medsafe.
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Communicate with global study teams and personnel on study progress.
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Identify risks to site activations and mitigate as necessary.
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Provide expertise and guidance to global study teams in ethics and regulatory submissions.
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Review and finalize essential documents required for site activation.
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Act as the main contact for ethical and regulatory submission‐related activities.
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Maintain direct contact with investigative sites during the study start‐up and activation process.
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Ensure submissions comply with applicable regulations and guidance documents.
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Advise sponsors on changing regulations and compliance requirements.




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Track submissions and ensure timely filing of documents.
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Qualifications
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Bachelor's degree in a science field or equivalent combination of education and experience.
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At least 1 year of relevant working experience at a CRO, pharmaceutical company, or investigative site.
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Experience in preparing and submitting TGA regulatory applications.
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Excellent organizational and communication skills.
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Knowledge of Microsoft Office.
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Knowledge of ICH‐GCP guidelines and regulatory guidelines in Australia and New Zealand.
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Hands‐on experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies, including formulating responses to queries.
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Proactive approach to the role with the ability and willingness to learn and be challenged.
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Perks
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Flexible work environment
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Competitive compensation and benefits package
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Competitive PTO packages
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Structured career paths with opportunities for professional growth
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Company‐sponsored employee appreciation events
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Employee health and wellness initiatives
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📌 Regulatory Submissions Coordinator (South Australia)
🏢 Medpace
📍 South Australia