Regulatory Affairs & Quality Associate

About the role

This permanent position is with an international pharmaceutical company operating in Australia. The role offers a broad, hands‑on experience across both Regulatory Affairs and Quality Assurance, supporting QMS management and regulatory submissions.

Key responsibilities

• Support day‑to‑day Quality Management System activities including deviations, CAPAs, change controls, complaints and documentation.
• Assist with TGA GMP clearances, applications, renewals and related documentation.
• Maintain regulatory dossiers, ARTG applications and product‑specific regulatory documentation.
• Review product labels, artwork and packaging for compliance and support batch release, product quality reviews and investigations.

Required profile

• Tertiary qualification in Pharmacy, Pharmaceutical Sciences, Life Sciences, Biotechnology, Chemistry, Microbiology or related field.
• Experience in pharmaceutical Quality Assurance, Regulatory Affairs or a related environment, with knowledge of GMP and QMS processes.

Required skills

• GMP knowledge
• Quality Management System (QMS) processes
• TGA regulatory requirements
• Regulatory submission preparation (ARTG)