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Senior Regulatory Compliance Coordinator

3 weeks ago

Melbourne, Victoria, Australia beBeeCompliance Full time $80,000 - $110,000
Job Title:

Regulatory Submissions Specialist

, About the Job

We are seeking a skilled Regulatory Submissions Specialist to join our Clinical Operations team in Melbourne, Australia. As a key member of our team, you will play a vital role in ensuring the success of our clinical trials by preparing and submitting regulatory documents to authorities.

Your primary responsibility will be to perform activities that lead to the activation of investigative sites in all phases of clinical trials. This includes preparing, reviewing, and submitting regulatory applications to the relevant authorities.

You will work closely with global study teams and personnel to ensure seamless communication and progress on study projects.

In addition, you will provide expertise and guidance to global study teams on ethics and regulatory submissions, review and finalize essential documents required for site activation, and act as the main point of contact for Ethical and Regulatory submission-related activities.

You will also have direct contact with investigative sites during the study start-up and activation process, ensure submissions comply with applicable regulations and guidance documents, and advise sponsors on changing regulations and compliance requirements.

To succeed in this role, you will need excellent organizational and communication skills, knowledge of Microsoft Office, and experience in preparing and submitting regulatory documentation to Ethics Committees and Regulatory Agencies.

, Required Skills and Qualifications
  • Bachelor's degree in a science field or equivalent combination of education and experience.
  • At least 1 year of relevant working experience at a CRO, Pharmaceutical Company, or an investigative site.
  • Experience in preparing and submitting regulatory applications to authorities.
  • Excellent organizational 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.
, Benefits

We offer a competitive compensation and benefits package, flexible work environment, structured career paths with opportunities for professional growth, and company-sponsored employee appreciation events.

, Awarded Companies
  • Recognized by Forbes as one of America's Most Successful Midsize Companies.
  • Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility.