Regulatory Operations Specialist

3 days ago

Brisbane, Queensland, Australia beBeeRegulatory Full time $120,000 - $160,000

Job Description:

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We are seeking a skilled Regulatory Start Up Manager to oversee the execution of regulatory start-up for assigned projects. Key responsibilities include defining a RSU strategy, preparing a RSU management plan, and collaborating with local regulatory start-up teams.

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Required Skills and Qualifications:

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  • A graduate degree in a clinical, pharmacy, or life sciences related field.
  • At least 5 years' experience in trial start-up and/or regulatory operations from a CRO or the pharmaceutical industry.
  • Strong knowledge of applicable regulations.
  • Able to manage in a matrix environment.
  • Confident decision-making and problem-solving skills.
  • Competent working in virtual teams across time zones.
  • Strong presentation, documentation, and interpersonal skills.
  • High proficiency in English.
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Benefits:

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This role offers the opportunity to work with a dynamic team, develop your skills, and contribute to the success of our organization.

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Others:

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You will be responsible for distributing start-up related documents, overseeing customization of core start-up documents, ensuring preparation and distribution of core contract and budget templates, and providing regional coordination for meeting approval timelines.

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In addition, you will oversee site activation package compilation and approvals, proactively identify risks to start-up, develop RSU mitigation plans, provide timely updates of regulatory start-up progress, and present at external and internal meetings.

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This role requires strong analytical and problem-solving skills, as well as excellent communication and interpersonal skills.

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