Senior Associate, Quality Assurance & Regulatory Affairs

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 agreements.
• Assist 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.