Global Regulatory Coordinator

2 days ago

Melbourne, Victoria, Australia beBeeRegulatory Full time $140,000 - $170,000
Job Title: Global Regulatory Coordinator

We are seeking a highly skilled and experienced professional to manage the preparation, review and coordination of Country Submissions in line with our global submission strategy.

  • Preparing, reviewing and coordinating local regulatory submissions (MoH, EC, additional special national local applications if applicable) in alignment with our global submission strategy.
  • Providing local regulatory strategy advice (MoH &/or EC) to internal clients.
  • Developing and implementing local submission strategy.
  • Providing technical expertise and coordination oversight for projects in collaboration with relevant internal departments.
  • Serving as primary contact for investigators and with the local regulatory authorities (in collaboration with the local regulatory manager for complex issues) to ensure submissions are managed in a timely manner.

To be successful in this role, you will have:

  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
  • Previous relevant study start up experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years).
  • Therapeutic experience in Oncology essential.
  • Phase I experience essential.
What We Offer

We offer competitive remuneration, annual incentive plan bonus, and a range of employee benefits. Our company culture stands for integrity, intensity, involvement, and innovation.

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