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Regulatory Documentation Expert

2 weeks ago

Sydney, New South Wales, Australia beBeeDocumentation Full time $90,000 - $120,000

Job Title: Regulatory Documentation Specialist

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We are seeking a highly skilled and detail-oriented Regulatory Documentation Specialist to join our team. As a key member of our regulatory team, you will play a crucial role in ensuring the quality and compliance of our regulatory documentation.

">About the Role

You will be responsible for preparing and reviewing clinical trial submission dossiers, including import and export license applications, and communicating with regulatory authorities, ethics committees, project teams, and vendors on regulatory-related matters.

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Main Responsibilities:

  • Preparing clinical trial submission dossiers for Regulatory and Ethics Authorities
  • Communicating with regulatory authorities, ethics committees, project teams, and vendors
  • Reviewing translations of essential documents subject to clinical trial submission
  • Tracking the regulatory project documentation flow
  • Reviewing documents to greenlight IP release to sites
  • Managing safety reporting to authorities
  • Delivering regulatory training to project teams
  • Assisting with feasibility research and business development requests
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Requirements:

  • University degree or an equivalent combination of education, training, and experience
  • 2-3 years' experience with clinical trial submissions in Australia
  • Ability to learn, plan, and work in a dynamic team environment
  • Communication, collaboration, and problem-solving skills
  • Knowledge of ICH-GCP guidelines and local regulatory requirements
  • Experience in preparing and reviewing regulatory submission documents
  • Strong organizational skills and ability to manage multiple projects simultaneously
  • Excellent time management skills to meet tight deadlines
  • Ability to interpret and apply complex regulatory guidelines
  • Willingness to stay updated on changing regulations and industry trends
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What We Offer:

  • Competitive salary
  • Hybrid work arrangement
  • Access to employee benefits
  • Additional wellness leave
  • Opportunities for development and learning
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This is an excellent opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research. If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply for this exciting role.

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