Global Regulatory Affairs & Quality Associate

Healthcare Professionals Group; Sydney; On-site; AUD 70,000 - 95,000; Full time

Benefits offered by this job

Permanent role

Global stakeholders exposure

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Regulatory Affairs

Quality Assurance

Documentation

Stakeholder management

Attention to detail

Time management

Independence

Education

Pharmacy degree

Life Sciences

Job description

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