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 Recent 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 environment where you will work across multiple areas of the business and have the opportunity to broaden your Regulatory Affairs and Quality Assurance experience.

📌 Senior Associate, Quality Assurance (Sydney)
🏢 Healthcare Professionals Group
📍 Sydney