
Global Regulatory Submissions Professional
3 days ago
We are seeking a seasoned professional to oversee the entire lifecycle of global regulatory submissions. The ideal candidate will have extensive experience in clinical research, preferably with a Contract Research Organization (CRO), and exceptional communication skills.
Main Responsibilities:- Manage all aspects of global start-up processes.
- Conduct thorough quality checks on submission documents and site essential documents.
- Develop and approve informed consent forms for various studies.
- Stay up-to-date with pertinent regulations to identify proactive solutions for start-up challenges.
- Present during bid defenses, general capabilities meetings, and audits.
- Over 5 years of experience in clinical research, preferably with a CRO.
- Regional experience is highly advantageous.
- Strong oral and written communication skills are crucial.
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Regulatory Submissions
3 weeks ago
Melbourne, Victoria, Australia Medpace Full timeRegulatory Submissions (Study Start-up) ManagerJoin to apply for the Regulatory Submissions (Study Start-up) Manager role at MedpaceRegulatory Submissions (Study Start-up) ManagerJoin to apply for the Regulatory Submissions (Study Start-up) Manager role at MedpaceWe are currently seeking a full-time, office-based* Study Start Up Submissions Manager to join...
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Regulatory Submissions
3 weeks ago
Melbourne, Victoria, Australia Medpace Full timeRegulatory Submissions (Study Start-up) ManagerJoin to apply for the Regulatory Submissions (Study Start-up) Manager role at MedpaceRegulatory Submissions (Study Start-up) ManagerJoin to apply for the Regulatory Submissions (Study Start-up) Manager role at MedpaceWe are currently seeking a full-time, office-based* Study Start Up Submissions Manager to join...
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Regulatory Submissions Coordinator
1 day ago
Melbourne, Victoria, Australia Medpace Full timeOverviewWe are currently seeking a full-time, office based Study Start up Submissions Coordinator Entry to join our Clinical Operations team in the Australia, Melbourne office. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company's success. If you are interested in an exciting career where you can use...
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Regulatory Submissions Coordinator
1 day ago
Melbourne, Victoria, Australia Medpace Full timeOverviewWe are currently seeking a full-time, office based Study Start up Submissions Coordinator Entry to join our Clinical Operations team in the Australia, Melbourne office. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company's success. If you are interested in an exciting career where you can use...
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Global Study Submissions Specialist
5 days ago
Melbourne, Victoria, Australia beBeeRegulatory Full time $100,000 - $115,000Global Study Submissions ManagerWe are seeking a highly skilled and experienced Global Study Submissions Manager to join our Clinical Operations team in Melbourne, Australia.Key Responsibilities:Manage and execute global study submissions efficiently;Perform quality checks on submission documents and site essential documents;Prepare and approve informed...
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Senior Regulatory Submissions Specialist
1 day ago
Melbourne, Victoria, Australia beBeeRegulatory Full time $100,000 - $140,000Job SummaryWe are seeking a full-time, office-based Regulatory Submissions Coordinator to join our Clinical Operations team in Australia.This role is instrumental to the team's success and offers an exciting career with opportunities for growth.Our culture empowers teams to employ their unique talents and experience to take an assertive approach to research,...
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Regulatory Affairs Professional
2 days ago
Melbourne, Victoria, Australia beBeeRegulatory Full time $90,000 - $144,000Regulatory Affairs & Operations ConsultantThis role involves preparing, reviewing and submitting regulatory dossiers to Medsafe and TGA.The ideal candidate will have a bachelor's degree in science, pharmacy or a related discipline.Key skills include experience in the review, critical evaluation and presentation of clinical data, as well as good knowledge of...
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Expert Regulatory Affairs Professional
6 hours ago
Melbourne, Victoria, Australia beBeeRegulatory Full time $80,000 - $120,000Regulatory Affairs ExpertiseJob DescriptionWe are seeking a highly skilled and experienced Regulatory Affairs professional to join our team. The successful candidate will play a key role in delivering high-quality regulatory outcomes, optimising submission strategies, and contributing to the continuous improvement of regulatory processes and team...
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Senior Regulatory Compliance Coordinator
18 hours ago
Melbourne, Victoria, Australia beBeeCompliance Full time $80,000 - $110,000Job Title:Regulatory Submissions Specialist, About the JobWe are seeking a skilled Regulatory Submissions Specialist to join our Clinical Operations team in Melbourne, Australia. As a key member of our team, you will play a vital role in ensuring the success of our clinical trials by preparing and submitting regulatory documents to authorities.Your primary...
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Healthcare Regulatory Compliance Professional
16 hours ago
Melbourne, Victoria, Australia beBeeRegulatory Full time $90,000 - $120,000Job DescriptionRegulatory Affairs SpecialistDevelop and execute a local regulatory plan in collaboration with internal stakeholders to ensure timely registration of our products and attainment of business objectives.Submit technical documentation to regulatory authorities and secure registration approval within the required timeframe.Maintain product...