Benefits
Permanent opportunity 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 Senior Associate, Quality Assurance & Regulatory Affairs to join an international pharmaceutical organisation. This is a broad, hands‐on position covering both Regulatory Affairs and Quality Assurance.
You will support regulatory submissions and lifecycle activities across Australia and New Zealand, while also contributing to the ongoing management of the Quality Management System, GMP compliance and broader quality activities.
This would suit someone with established pharmaceutical RA and/or QA experience who enjoys working across both functions and is looking for broader responsibility and exposure.
Duties
Prepare, submit and manage regulatory applications to the TGA and Medsafe
Support regulatory activities throughout pre-submission, submission and evaluation
Coordinate responses to Health Authority questions and requests
Maintain regulatory dossiers, submission records and product‐specific documentation
Support ARTG applications, variations, renewals and ongoing product lifecycle activities
Review Product Information, labels, artwork, packaging and related materials for compliance
Assess regulatory impact of manufacturing, supplier, formulation, packaging and testing changes




Support TGA GMP clearances, including applications, renewals and supporting documentation
Maintain and support Quality Management System activities including deviations, CAPAs, change controls and complaints
Support supplier qualification, vendor compliance and quality agreementsAssist with product quality reviews, recalls, investigations and batch release activities
Support audit, inspection and compliance readiness
Skills and Experience
Tertiary qualification in Pharmacy, Pharmaceutical Sciences, Life Sciences, Biotechnology, Chemistry, Microbiology or a related discipline
3 to 5 years' experience within pharmaceutical Regulatory Affairs or Quality Assurance
Experience supporting or managing regulatory submissions
Knowledge of TGA regulatory requirements, with Medsafe exposure highly regarded
Good understanding of GMP requirements and pharmaceutical quality systems
Experience across QMS activities such as deviations, CAPAs, change controls or complaints advantageous
Experience within a pharmaceutical sponsor, manufacturer or distribution environment highly regarded
Strong attention to detail and documentation skills
Strong organisation and time management skills with the ability to manage competing priorities
Excellent communication and stakeholder management skills
Ability to work independently while collaborating effectively across teams
Culture
Join a collaborative and quality-focused setting 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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📌 Senior Associate, Quality Assurance & Regulatory Affairs (Sydney)
🏢 Healthcare Professionals Group
📍 Sydney