Responsibilities

  • Prepare and submit regulatory applications, dossiers, and compliance documentation.
  • Support the registration and listing of pharmaceuticals, biologicals, and medical devices.
  • Review and critically evaluate regulatory dossiers for submission to the TGA and Medsafe.
  • Assist clients with responses to questions from regulatory authorities.
  • Support lifecycle maintenance of existing registrations and listings.
  • Prepare GMP clearance applications.
  • Prepare, review, and update quality documentation.
  • Support project management and client-management activities.
  • Assist with the development of client proposals.
  • Collaborate with other teams.

Requirements

  • Undergraduate qualification in pharmaceutical sciences or another relevant scientific discipline.
  • Minimum of three years of experience in Australian and New Zealand regulatory affairs or quality, preferably within a commercial environment.
  • Good knowledge of TGA and Medsafe legislation, regulations, guidelines, and working procedures.
  • Strong written and verbal communication skills.
  • Good problem-solving and project-management capabilities.
  • Ability to manage confidential information.
  • Strong attention to detail and ability to work to deadlines.
  • Interest in consulting and continuous professional development.
  • Fluent English.

Publish Date

21 August, 2026

Spontaneous Application

Regulatory Affairs Officer / Associate Consultant - VAF 644

New opportunities open up across PLG all the time. If nothing matches right now, send us a spontaneous application: we will keep you in mind for what comes next.

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