Regulatory Start Up Manager
vor 2 Wochen
Overview Join to apply for the Regulatory Start Up Manager role at Novotech Define a Regulatory Start Up (RSU) strategy and prepare an RSU management plan. Oversee the execution of regulatory start up for assigned projects in accordance with the agreed RSU strategy. Ensure collaboration with local regulatory start up teams to successfully deliver the agreed project scope in compliance with the RSU management plan. Distribute start up related documents to local regulatory start up teams. Oversee customization of core start-up documents to local requirements. Ensure preparation and distribution of core contract and budget templates to applicable team members. Oversee submission processes to health authorities, ethics committees and other review bodies. Provide regional coordination for meeting approval timelines. Oversee site activation package compilation and approvals. Proactively identify any risks to start up and escalate to Project Manager. Provide timely update of regulatory start up progress to Project Manager. Present at external and internal meetings including but not limited to project internal and external meetings, kick-off meetings. Experience and Qualifications Graduate in a clinical, pharmacy or life sciences related field. Experience managing start up in more than one country and/or region. At least 3 years' experience from a CRO or the pharmaceutical industry in activities related to trial start-up and/or regulatory operations. Through knowledge of applicable regulations. Able to manage in a matrix environment. Confident decision-making and problem-solving. Strong presentation, documentation, and people skills. High proficiency in English. Employer overview : Novotech is committed to an inclusive work environment where everyone is treated fairly and with respect. We support flexible working options, parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are an equal opportunity employer and encourage applications from people of all backgrounds, including those who identify as LGBTIQ+, have a disability or have caring responsibilities. We respond to every application as part of our Circle Back initiative. #J-18808-Ljbffr
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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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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...
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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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Senior Regulatory Start-Up Specialist – Australia
vor 2 Wochen
City of Melbourne, Österreich at VollzeitA leading clinical research organization in Melbourne is seeking a Senior Regulatory Start Up Associate. This role involves planning and reviewing regulatory submissions, providing guidance on local regulations, and ensuring compliance with timelines. The ideal candidate will have a graduate degree in a relevant field and 3-5 years of experience in a CRO or...
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Senior Regulatory Start-Up Specialist
vor 2 Wochen
City of Melbourne, Österreich Novotech VollzeitA research organization in Australia seeks a Senior Regulatory Start Up Associate responsible for planning and review of regulatory applications and submissions. This role involves serving as a key contact for project managers and ensuring compliance with local regulations. Ideal candidates will have a degree in life sciences and 3-5 years of experience in...
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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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Clinical Trials Study Start-Up Specialist
vor 3 Wochen
City of Melbourne, Österreich Veritus Research VollzeitClinical Trials Study Start-Up Specialist Veritus Research is an exciting new clinical trial business for First in Human, Phase 1, and vaccine clinical trials. Our Trial Advancement team is expanding, and we are seeking a Clinical Trials Study Start-Up Specialist to join us at our state-of-the-art clinical trials facility in Bayswater, Victoria. This is an...
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Feasibility and Start Up Specialist
vor 2 Wochen
Melbourne, Österreich The Royal Melbourne Hospital VollzeitOverview Join to apply for the Feasibility and Start Up Specialist role at The Royal Melbourne Hospital . Be a key member of the RMH clinical research enabling team in a position with broad career boosting exposure. The role is responsible for the coordination and preparation of feasibility and start up for commercially sponsored projects at the Royal...
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CFO | Construction Manufacturing Start Up
vor 4 Wochen
City of Melbourne, Österreich Xprt Dev VollzeitCFO | Construction Manufacturing Start Up location_pin Redbank, QLD money_bag A$250,000 p/a + Super + Share/bonus options. home_work On-site Posted 1 day ago Chief Financial Officer | Construction Manufacturing Start Up Redbank | Brisbane Permanent - Full time - Mon to Fri Circa $250k base + Super + Share options and bonuses available. About the opportunity...
