Regulatory Submissions
vor 3 Wochen
We are currently seeking a full-time, office-based* Study Start Up Submissions Manager to join our Clinical Operations team in Melbourne, Australia. *With potential hybrid working arrangements Responsibilities Efficiently manage and successfully execute all aspects of global start-up; Perform quality checks on submission documents and site essential documents; Prepare and approve informed consent forms; Review pertinent regulations to develop proactive solutions to start-up issues and challenges; and Present during bid defenses, general capabilities meetings, and audits. Qualifications More than 5 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience; Regional experience will be highly advantageous; Strong oral and written communication skills. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks 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 Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps. #J-18808-Ljbffr
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Senior Regulatory Submission Specialist
vor 2 Wochen
Council of the City of Sydney, Österreich ICON Clinical Research VollzeitSenior Regulatory Submission Specialist Senior Regulatory Submission Specialist to join us in a home-based in Australia ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of...
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Regulatory Submissions Coordinator
vor 1 Woche
Melbourne, Österreich Medpace VollzeitOverview We 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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Council of the City of Sydney, Österreich ICON Clinical Research VollzeitA leading clinical research organization is seeking a Senior Regulatory Submission Specialist to oversee regulatory submissions across Australia and New Zealand. This home-based role demands strong ICH-GCP knowledge and 3 years of regulatory experience in a CRO or pharmaceutical setting. The successful candidate will manage submission documentation, engage...
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City of Greater Bendigo, Österreich Coliban Water VollzeitA regional water corporation in Victoria is seeking a Program Manager for Strategic and Regulatory Initiatives. The role involves managing major strategic submissions like the Pricing Submission and Urban Water Strategy. Ideal candidates will have strong project management and stakeholder engagement skills, as well as proven experience in coordinating...
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Regulatory Submissions
vor 2 Wochen
Melbourne, Österreich Medpace VollzeitRegulatory Submissions (Study Start-up) Manager Join to apply for the Regulatory Submissions (Study Start-up) Manager role at Medpace Regulatory Submissions (Study Start-up) Manager Join to apply for the Regulatory Submissions (Study Start-up) Manager role at Medpace We are currently seeking a full-time, office-based* Study Start Up Submissions Manager to...
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Global Regulatory Submissions Director
Vor 7 Tagen
Townsville City, Österreich Precision Medicine Group VollzeitA life sciences organization in Townsville City is looking for a Director Regulatory Affairs to oversee global regulatory submissions. The ideal candidate will have extensive experience and a Post Graduate Degree, able to lead teams in developing regulatory strategies and ensuring compliance. Strong leadership and departmental enhancement skills are...
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Country Start-Up Specialist
vor 1 Tag
Council of the City of Sydney, Österreich Thermofisher Scientific VollzeitA global clinical research firm is seeking a Country Approval Specialist in Sydney, Australia. Key Responsibilities Manage regulatory submissions and ensure site activation. Qualifications Strong attention to detail and 1+ years of experience in start‑up operations. This role offers comprehensive health benefits, flexible working arrangements, and...
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Council of the City of Sydney, Österreich Icon VollzeitA top-tier healthcare organization in Australia is looking for a Senior Regulatory Affairs Specialist to manage regulatory submissions and ensure compliance with local regulations. The role requires collaboration with health authorities and managing product registrations. Candidates should have a strong background in regulatory affairs and excellent...
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Country Start-Up Specialist: Regulatory Submissions
vor 2 Wochen
Council of the City of Sydney, Österreich ThermoFisher Scientific VollzeitA global clinical research firm is seeking a Country Approval Specialist in Sydney, Australia. The ideal candidate will manage regulatory submissions and ensure site activation while demonstrating strong attention to detail and 1+ years of experience in start-up operations. This role offers comprehensive health benefits, flexible working arrangements, and...
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City of Greater Bendigo, Österreich Coliban Water VollzeitA leading regional urban water corporation in Victoria is seeking a Program Manager for Strategic and Regulatory Initiatives. This permanent full-time role involves end-to-end management of major submissions, ensuring alignment with strategic objectives. The ideal candidate will have strong project management skills, excellent written communication, and...
