Global Regulatory Submissions Professional

3 days ago


Melbourne, Victoria, Australia beBeeRegulatory Full time $100,000 - $115,000
Global Regulatory Submissions Manager

We are seeking a seasoned professional to oversee the entire lifecycle of global regulatory submissions. The ideal candidate will have extensive experience in clinical research, preferably with a Contract Research Organization (CRO), and exceptional communication skills.

Main Responsibilities:
  • Manage all aspects of global start-up processes.
  • Conduct thorough quality checks on submission documents and site essential documents.
  • Develop and approve informed consent forms for various studies.
  • Stay up-to-date with pertinent regulations to identify proactive solutions for start-up challenges.
  • Present during bid defenses, general capabilities meetings, and audits.
Key Requirements:
  • Over 5 years of experience in clinical research, preferably with a CRO.
  • Regional experience is highly advantageous.
  • Strong oral and written communication skills are crucial.


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