Expert Regulatory Compliance Specialist

2 weeks ago

Melbourne, Victoria, Australia beBeeRegulatory Full time $90,000 - $120,000

Regulatory submissions are a vital aspect of our operations.

We seek an experienced coordinator to oversee and manage the regulatory submission process from start to finish, ensuring compliance with relevant regulations and guidelines. This individual will work closely with our clinical operations team to activate investigative sites across all phases of clinical trials, prepare and review regulatory applications for agencies such as TGA and Medsafe, and provide expertise and guidance to global study teams on ethics and regulatory submissions.

Responsibilities:
  • Activate investigative sites in Australia for all clinical trial phases;
  • Prepare, review, and submit regulatory applications to agencies such as TGA and Medsafe;
  • Communicate with global study teams and personnel on study progress;
  • Identify risks to site activations and mitigate as necessary;
  • Provide expertise and guidance to global study teams on ethics and regulatory submissions;
  • Review and finalize essential documents required for site activation;
  • Main contact for Ethical and Regulatory submission-related activities;
  • Direct contact with investigative sites during the study start-up and activation process;
  • Ensure submissions comply with applicable regulations and guidance documents;
  • Advise sponsors on changing regulations and compliance requirements;
  • Track submissions and ensure timely filing of documents.
Qualifications:
  • Bachelor's degree in a science field or equivalent combination of education and 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;
  • Knowledge of ICH-GCP guidelines and regulatory guidelines in Australia and New Zealand;
  • Hands-on experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies;
  • Proactive approach to the role with ability and willingness to learn and be challenged.

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