Regulatory Operations Manager

3 days ago

Melbourne, Victoria, Australia beBeeRegulatory Full time $120,000 - $175,000
Regulatory Start Up Specialist

The Regulatory Start Up Specialist is a critical role in driving regulatory start up strategies for assigned projects. The specialist must define and execute comprehensive RSU plans to ensure successful project delivery.

  • Develop strategic plans and prepare RSU management documents to meet project objectives.
  • Collaborate with local regulatory teams to oversee the execution of RSU activities, ensuring timely coordination and collaboration.
  • Facilitate the distribution of essential documents to support project progress.
  • Customize start-up documents to meet local requirements, streamlining the process.
  • Coordinate the preparation and distribution of templates to relevant team members.
  • Ensure efficient submission processes to health authorities, ethics committees, and review bodies, meeting approval timelines through regional coordination.
  • Compile and obtain approvals for site activation packages.
  • Proactively identify potential risks to RSU and escalate to the Project Manager to ensure prompt mitigation.
  • Provide regular updates on RSU progress to the Project Manager to foster transparency.
Experience and Qualifications
  • A graduate degree in a clinical, pharmacy, or life sciences related field.
  • Experience managing regulatory start up in multiple countries and/or regions.
  • At least 3 years' experience from a CRO or the pharmaceutical industry in trial start-up and/or regulatory operations, leveraging deep knowledge of applicable regulations.
  • Ability to navigate matrix environments effectively.
  • Confident decision-making and problem-solving skills, driving success.
  • Strong presentation, documentation, and interpersonal skills.
  • High proficiency in English.

We Foster an Inclusive Work Environment where everyone is treated fairly and with respect. We offer flexible working options, parental leave, flexible leave entitlements, wellness programs, and ongoing development programs. As an equal opportunity employer, we encourage applications from diverse backgrounds. Our Circle Back initiative ensures timely responses to every application.

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