Global Regulatory Affairs Specialist (Melbourne, Australia)

Global Regulatory Affairs Specialist (Melbourne, Australia)

  • Location

    Melbourne, Victoria

  • Sector:

    Regulatory Affairs

  • Job type:


  • Salary:


  • Contact:

    Freddie Hill

  • Contact email:


  • Job ref:


  • Published:

    7 months ago

  • Expiry date:


  • Consultant:


Job title: Global Regulatory Affairs Specialist (Melbourne, Australia)

A specialist pharmaceutical business headquartered in Melbourne are seeking a Regulatory affairs Specialist to join their team. The responsibilities of this role include maintenance of global product listings, quality, relevance, and accuracy of product information across multiple territories.


  • Provide informed, accurate and up-to-date regulatory guidance in production quality, drug safety, compliance, and clinical trials to all stakeholders.
  • Monitor and interpret international regulations, standards, guidelines, and prescribing practices in all relevant markets.
  • Be the primary point of contact with Regulators and establish strong working relationships with various stakeholders which will include relevant Health Authorities.
  • Review, interpret and effectively communicate all regulatory requirements to Production department.


  • Previous experience engaging with the TGA.
  • Experience in liaising with MHRA/EMA.
  • Experience with prescription drug registration submissions and lifecycle management, including clinical trial activities.
  • Life Science Degree would be beneficial.

Salary and benefits:

A competitive salary and benefits package is on offer for this role.

To apply for this position or hear further details then please contact Freddie Hill via Freddie.hill@pharma-partners.co.uk