Regulatory Affairs & Quality Associate

Healthcare Professionals Group; Sydney; Presencial; AUD 70.000 - 95.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Permanent role

Global stakeholders exposure

Descripción de la vacante

Healthcare Professionals Group in Sydney is seeking a Regulatory Affairs & Quality Associate to join a global pharmaceutical company. This broad, hands-on role spans QA and RA activities, supporting the ongoing management of the QMS and exposure to regulatory submissions, product lifecycle activities, artwork and labeling, TGA requirements and GMP clearances.

You will collaborate with local, regional and global stakeholders, maintain regulatory documentation, review product labels, and

Formación

• Tertiary qualification in Pharmacy, Pharmaceutical Sciences, Life Sciences, Biotechnology, Chemistry or Microbiology.
• Experience in pharmaceutical QA or regulatory affairs.
• Understanding of GMP and QMS processes.
• Knowledge of TGA regulatory requirements is advantageous.

Responsabilidades

• Support day-to-day QMS activities including deviations, CAPAs, change controls, complaints and documentation.
• Assist with document control, SOPs, training records and continuous improvement.
• Support TGA GMP clearances, including applications, renewals and tracking.
• Assist with supplier qualification and quality agreements.
• Support batch release, product quality reviews and investigations.
• Maintain regulatory dossiers and submission records.
• Support ARTG applications and regulatory submission documentation.
• Review labels and artwork for regulatory compliance; support lifecycle activities.

Conocimientos

Regulatory Affairs

Quality Assurance

Documentation

Stakeholder management

Attention to detail

Time management

Independence

Educación

Pharmacy degree

Life Sciences

Descripción del empleo

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 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.