Benefits
Permanent prospect within an international pharmaceutical company
Broad role across both Regulatory Affairs and Quality Assurance
Work closely with local, regional and global stakeholders
About the company
A global pharmaceutical organisation with an established Australian presence and a strong commitment to quality, compliance and patient outcomes.
About the opportunity
An exciting opportunity has become available for a Regulatory Affairs & Quality Associate to join a growing pharmaceutical organisation.
This is a broad, hands-on role spanning both QA and RA activities.
You will support the ongoing management of the QMS while also gaining exposure to regulatory submissions, product lifecycle activities, artwork and labelling, TGA requirements and GMP clearances.
Duties
Support day-to-day Quality Management System activities including deviations, CAPAs, change controls, complaints and quality documentation
Assist with document control, SOPs, training records and continuous improvement activities
Support TGA GMP clearances, including applications, renewals, supporting documentation and tracking
Assist with supplier qualification, vendor compliance and quality agreements
Support batch release, product quality reviews, complaints, recalls and quality investigations
Maintain regulatory dossiers, submission records and product-specific regulatory documentation




Support ARTG applications and preparation of regulatory submission documentation
Review product labels, artwork and packaging for regulatory complianceSupport product lifecycle activities including registrations, variations, renewals and regulatory approvals
Skills and Experience
Tertiary qualification in Pharmacy, Pharmaceutical Sciences, Life Sciences, Biotechnology, Chemistry, Microbiology or a related discipline
Experience within pharmaceutical Quality Assurance, Regulatory Affairs or a related environment
Understanding of GMP requirements and pharmaceutical quality systems
Exposure to QMS processes such as deviations, CAPAs, change controls or complaints would be highly regarded
Knowledge or exposure to TGA regulatory requirements would be advantageous
Experience within a pharmaceutical sponsor, manufacturer or distribution environment would be beneficial
Strong attention to detail and documentation skills
Excellent organisation and time management skills with the ability to manage competing priorities
Strong communication and stakeholder management skills
Ability to work independently while contributing effectively within a cross-functional team
Culture
Join a collaborative and quality-focused environment where you will work across multiple areas of the business and have the opportunity to broaden your Regulatory Affairs and Quality Assurance experience.
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📌 Regulatory Affairs & Quality Associate (Sydney)
🏢 Healthcare Professionals Group
📍 Sydney