Senior QA & Regulatory Affairs Specialist — Global Pharma

Health and Aged Care Professionals; Sydney; On-site; AUD 120,000 - 160,000; Full time

Benefits offered by this job

Permanent role

Broad RA/QA exposure

Global stakeholder interaction

Job summary

Health and Aged Care Professionals in Sydney, NSW seeks a Senior Associate, Quality Assurance & Regulatory Affairs to drive regulatory submissions and quality activities across ANZ. The role covers RA and QA, supporting GMP compliance and quality system management with cross-functional teams.

You will work with local, regional and global stakeholders to ensure lifecycle activities, product information and labeling meet regulatory standards while advancing patient outcomes.

Qualifications

• Tertiary qualification in Pharmacy or related discipline.
• Experience in Regulatory Affairs or Quality Assurance in pharma is required.
• Strong documentation and attention to detail.

Responsibilities

• Prepare, submit and manage regulatory applications to TGA/Medsafe.
• Support regulatory lifecycle activities across Australia and NZ.
• Maintain Quality Management System and GMP compliance.
• Contribute to product quality reviews, deviations and CAPAs.
• Coordinate audits, inspections and supplier quality activities.

Education

Bachelor's degree in Pharmacy or related Life Sciences

Job description

Health and Aged Care Professionals in Sydney, NSW seeks a Senior Associate, Quality Assurance & Regulatory Affairs to drive regulatory submissions and quality activities across ANZ. The role covers RA and QA, supporting GMP compliance and quality system management with cross-functional teams.

You will work with local, regional and global stakeholders to ensure lifecycle activities, product information and labeling meet regulatory standards while advancing patient outcomes.