Global Regulatory Start Up Specialist

3 days ago

Melbourne, Victoria, Australia beBeeRegulatory Full time $93,528 - $124,116

Job Title: Regulatory Start Up Manager

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The Regulatory Start Up Manager plays a pivotal role in defining and implementing a regulatory start up strategy for assigned projects. This involves creating and overseeing the execution of RSU management plans, ensuring seamless collaboration with local regulatory start up teams to deliver project scope in compliance with established guidelines.

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Key responsibilities include:

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  • Distributing relevant documents to local regulatory start up teams;">
  • Overseeing customization of core start-up documents to meet local requirements;">
  • Ensuring timely preparation and distribution of core contract and budget templates to applicable team members;">
  • Coordinating submission processes to health authorities, ethics committees, and other review bodies;">
  • Providing regional coordination for meeting approval timelines;">
  • Compiling site activation package approvals;">
  • Proactively identifying risks to start up and escalating them to Project Managers;">
  • Presenting at external and internal meetings, including but not limited to project internal and external meetings, kick-off meetings.">
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A graduate in a clinical, pharmacy, or life sciences related field is required, along with 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 is necessary, as well as thorough knowledge of applicable regulations.

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The ideal candidate will be able to manage in a matrix environment, possess confident decision-making and problem-solving skills, and have strong presentation, documentation, and people skills. High proficiency in English is also required.

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