Senior Regulatory & Validation Lead - ARTG/GMP Compliance

Star Combo Australia; Sydney; On-site; AUD 100,000 - 140,000; Full time

Job summary

Star Combo Australia seeks a Senior Validation/Regulatory Affairs Associate to drive regulatory compliance for Sydney-based operations in a complementary manufacturing environment. You will oversee QA/regulatory activities, support ARTG submissions, and ensure GMP compliance across labeling, packaging and documentation.

The role requires a Bachelor of Science or Engineering and at least 2 years in regulatory affairs, with knowledge of Australian TGA regulations and HACCP principles.

Qualifications

• Bachelor of Science or engineering degree or equivalent.
• Minimum 2 years’ experience in regulatory affairs in a similar industry.
• Experience with GMP regulations and QA activities.
• Familiarity with ARTG listing and regulatory submissions in Australia.

Responsibilities

• Lead senior QA/Regulatory Affairs activities.
• Provide regulatory input for premarket and post-market activities.
• Review labelling, packaging and promotional materials for compliance.
• Coordinate product registration and ARTG listing submissions.
• Maintain the quality system and specifications for materials and finished products.
• Support Sales, Production, Operations with regulatory/technical issues.
• Maintain licenses and MVP programs including IQ/OQ/PQ and validations.

Skills

Regulatory affairs

Quality assurance

GMP compliance

Documentation

Education

Bachelor of Science or Engineer

Job description

Star Combo Australia seeks a Senior Validation/Regulatory Affairs Associate to drive regulatory compliance for Sydney-based operations in a complementary manufacturing environment. You will oversee QA/regulatory activities, support ARTG submissions, and ensure GMP compliance across labeling, packaging and documentation.

The role requires a Bachelor of Science or Engineering and at least 2 years in regulatory affairs, with knowledge of Australian TGA regulations and HACCP principles.