Regulatory Submissions Co-ordinators (x3)

Via mexec careers

The client is a global, full-service Clinical Research Organization (CRO) specializing in a multitude of therapeutic areas and active in over 45 countries globally. Due to continual growth they are seeking a full time Regulatory Submissions Manager to join their operations based in Melbourne.

The client has a culture of expertise that empowers teams to support their business partners. Their values are high, and recognition and advancement are incremental to their success. Their team is stable and long term, and their employees are valued. Just a few reasons why mexec careers choose to represent this employer.

The Opportunity

Due to continual growth our client is seeking 3 full time Regulatory Submissions Co-coordinators to join their operations based in Melbourne. Your role primarily will be responsible for:

Perform required activities within the country that lead to activation of investigative sites in all phases

  • Prepare, review, and submit to Regulatory Agencies (TGA / Medsafe)
  • Communicate with global study teams and personnel on study progress
  • Ability to effectively identify risks to site activations and mitigate as necessary
  • Provide expertise and guidance to global study teams in ethics and regulatory submission
  • ┬áReview and finalize essential documents required for site activation
  • Act as a 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.

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