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.
Responsibilities
- Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials.
- Prepare, review, and submit regulatory documents to agencies such as TGA and Medsafe.
- Communicate with global study teams and personnel on study progress.
- Identify risks to site activations and mitigate as necessary.
- Provide expertise and guidance to global study teams in ethics and regulatory submissions.
- Review and finalize essential documents required for site activation.
- Act as the main contact for ethical and regulatory submission‐related activities.
- Maintain direct contact with investigative sites during the study start‐up and activation process.
- Ensure submissions comply with applicable regulations and guidance documents.
- Advise sponsors on changing regulations and compliance requirements.
- Track submissions and ensure timely filing of documents.
Qualifications
- Bachelor's degree in a science field or equivalent combination of education and experience.
- At least 1 year of relevant working experience at a CRO, pharmaceutical company, or investigative site.
- Experience in preparing and submitting TGA regulatory applications.
- Excellent organizational and communication skills.
- Knowledge of Microsoft Office.
- Knowledge of ICH‐GCP guidelines and regulatory guidelines in Australia and New Zealand.
- Hands‐on experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies, including formulating responses to queries.
- Proactive approach to the role with the ability and willingness to learn and be challenged.
Benefits
- Flexible work environment
- Competitive compensation and benefits package
- Competitive PTO packages
- Structured career paths with opportunities for professional growth
- Company‐sponsored employee appreciation events
- Employee health and wellness initiatives
Regulatory Submissions Coordinator employer: Medpace
Medpace is an exceptional employer, offering a dynamic work environment in Melbourne that fosters professional growth and development within the clinical research field. With a strong focus on employee well-being, competitive compensation, and flexible working arrangements, Medpace supports its team members in achieving their career aspirations while contributing to meaningful advancements in medical therapeutics. Join a globally recognized leader in the CRO industry, where your expertise will be valued and your contributions will make a real impact.
