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Global Regulatory Affairs Specialist (Melbourne, Australia)

Global Regulatory Affairs Specialist (Melbourne, Australia)

  • Location

    Melbourne, Victoria

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Freddie Hill

  • Contact email:

    freddie.hill@pharma-partners.net

  • Job ref:

    26494_1638953923

  • Published:

    about 2 months ago

  • Expiry date:

    2022-01-07

  • 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.

Responsibilities:

  • 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.

Requirements:

  • 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