Clinical Research Expert

1 week ago

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

Job Profile:

The Regulatory Submission Specialist role is responsible for overseeing the regulatory submission process, ensuring timely and compliant submissions to support business objectives.

Key Responsibilities:

  • Communicate with regulatory authorities, ethics committees, project teams, and vendors on regulatory matters.
  • Manage the flow of regulatory project documentation.
  • Review documents to enable IP release to sites.
  • Coordinate safety reporting to authorities.
  • Deliver training to project teams on regulatory compliance.
  • Support feasibility research and business development requests.

Requirements and Qualifications:

  • University degree or equivalent combination of education, training, and experience.
  • 2-3 years of experience in clinical trial submissions in Australia.
  • Ability to learn, plan, and work in a dynamic team environment.
  • Strong communication, collaboration, and problem-solving skills.
  • Knowledge of ICH-GCP guidelines and local regulatory requirements.
  • Experience in preparing and reviewing regulatory submission documents.
  • Excellent organizational skills and ability to manage multiple projects simultaneously.
  • Effective time management skills to meet deadlines.
  • Commitment to staying updated on changing regulations and industry trends.

Personal and Professional Development:

This opportunity allows you to further develop your skills, expand your therapeutic area experience, and become an expert in clinical research.

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