Regulatory Submissions Specialist

4 days ago

Melbourne, Victoria, Australia beBeeRegulatory Full time $90,000 - $150,000

Job Opportunity: Regulatory Submissions Expertise

We are seeking a highly skilled and experienced Regulatory Submissions Coordinator to join our Clinical Operations team in Melbourne, Australia.

This role plays a crucial part in driving company success through accomplishment of tasks and projects.

  • Activate investigative sites across all clinical trial phases within Australia.
  • Prepare, review, and submit regulatory documents to agencies such as the TGA and Medsafe.
  • Communicate with global study teams on study progress and provide expertise on ethics and regulatory submissions.
  • Identify and mitigate risks to site activations and advise sponsors on changing regulations and compliance requirements.
  • Track submissions and ensure timely filing of documents.

Key Qualifications:

  • Bachelor's degree in a science field or equivalent experience.
  • At least 2 years of relevant working experience at a CRO, pharmaceutical company, or investigative site.
  • Experience in preparing and submitting TGA regulatory applications.
  • Excellent organization and communication skills.
  • Knowledge of Microsoft Office and ICH-GCP guidelines.

Why Choose Us?

  • Flexible work environment.
  • Competitive compensation package.
  • Structured career paths with opportunities for professional growth.

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