Regulatory Affairs & Quality AssociateNew

Health and Aged Care Professionals; Sydney; On-site; AUD 90,000 - 120,000; Full time

Benefits offered by this job

Permanent role

Broad RA/QA scope

Stakeholder engagement

Job summary

Health and Aged Care Professionals is seeking a Regulatory Affairs & Quality Associate in Sydney to support the QMS and regulatory submissions across RA/QA activities.

You will work with local, regional and global stakeholders on GMP clearances, product lifecycle, labeling and ARTG submissions, while maintaining quality documentation and compliance.

Qualifications

• Tertiary qualification in Pharmacy, Pharmaceutical Sciences, Life Sciences, Biotechnology, Chemistry or Microbiology.
• Experience within pharmaceutical Quality Assurance or Regulatory Affairs.
• Knowledge of GMP and pharmaceutical quality systems.
• Exposure to TGA regulatory requirements is advantageous.
• Strong documentation and attention to detail.
• Excellent organisation and time management skills.

Responsibilities

• Support day-to-day Quality Management System activities (deviations, CAPAs, change controls, complaints).
• Assist with document control, SOPs and training records.
• Help with TGA GMP clearances, applications and documentation.
• Assist with supplier qualification, vendor compliance and quality agreements.
• Support batch release, product quality reviews and investigations.
• Maintain regulatory dossiers and submission records.
• Review ARTG registrations and regulatory submission documents.
• Check product labels, artwork and packaging for compliance.
• Support lifecycle activities including variations and regulatory approvals

Skills

Quality Assurance

Regulatory Affairs

Documentation

GMP

Stakeholder management

Attention to detail

Education

Pharmacy/Life Sciences degree

Tools

QMS software

Job description

Health and Aged Care Professionals - Sydney NSW

2d ago , from Health and Aged Care Professionals

• Permanent opportunity within an international pharmaceutical company
• Broad role across both Regulatory Affairs and Quality Assurance
• Work closely with local, regional and global stakeholders

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 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 compliance
• Support 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.