Regulatory Submissions
vor 2 Wochen
Regulatory 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 join our Clinical Operations team in Melbourne, Australia.ResponsibilitiesEfficiently 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. QualificationsMore 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. With potential hybrid working arrangements Medpace OverviewMedpace 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 PerksFlexible 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 AwardsRecognized 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 NextA Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps. Seniority level Seniority level Not Applicable Employment type Employment type Full-time Job function Job function Legal Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Medpace by 2x Get notified about new Regulatory Specialist jobs in South Yarra, Victoria, Australia . 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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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Regulatory Submissions
vor 3 Wochen
City of Melbourne, Österreich Medpace VollzeitWe 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...
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Regulatory Manager
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City of Melbourne, Österreich Rainbow Agro VollzeitPosition: Regulatory Affairs Manager Australia & New Zealand Location: Melbourne or Sydney, Australia Reports to: Product Manager Australia Overview Rainbow Agro is a world leading off‑patent agrochemical company headquartered in China. It is the #1 exporter of agrochemicals in China and holds a comprehensive list of global registrations, enabling the...
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Regulatory Manager
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City of Melbourne, Österreich Davidson VollzeitAbout the Opportunity An exciting opportunity has emerged to join one of Australia’s most dynamic renewable energy and infrastructure organisations, now entering a major project delivery phase. This role offers a front-row seat to one of Australia’s most significant infrastructure developments, with the opportunity to influence policy, shape investment...
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Associate Director- Case Management Intake
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City of Melbourne, Österreich CSL Limited VollzeitAssociate Director- Case Management Intake & Submissions CSL's R&D organisation is accelerating innovation to deliver greater impact for patients. With a project‑led structure and a focus on collaboration, we’re building a future‑ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to...
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Regulatory Affairs Senior Specialist
vor 3 Wochen
City of Melbourne, Österreich at VollzeitAdd expected salary to your profile for insights Position Title: Regulatory Affairs Senior Specialist Reports To: Quality and Regulatory Lead Location(s): Australia Purpose of the Function The Regulatory Affairs Senior Specialist is responsible for maintaining a portfolio of products, preparing regulatory applications for submission, promoting regulatory...
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Regulatory Submissions Lead – Study Start-up, Hybrid
vor 3 Wochen
City of Melbourne, Österreich Medpace VollzeitA global clinical research organization is looking for a full-time Study Start Up Submissions Manager in Melbourne, Australia. The role involves managing global start-up activities, performing quality checks, and ensuring compliance with regulations. Candidates should have over 5 years of clinical research experience, preferably with a contract research...
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Senior Regulatory Start Up Associate
vor 2 Wochen
City of Melbourne, Österreich at VollzeitSenior Regulatory Start Up Associate - Australia The Senior Regulatory Start Up Associate is primarily responsible for planning, preparation, review of country and site level ethics and regulatory authority applications and submissions during project start-up, in compliance with ICH-GCP and local regulatory requirements, to ensure timely clinical trial...
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Senior Regulatory Start Up Associate
vor 2 Wochen
City of Melbourne, Österreich Novotech VollzeitSenior Regulatory Start Up Associate - Australia The Senior Regulatory Start Up Associate is primarily responsible for planning, preparation, and review of country and site‑level ethics and regulatory authority applications and submissions during project start‑up, in compliance with ICH‑GCP and local regulatory requirements, to ensure timely clinical...
