Senior Validation/Regulatory Affairs Associate

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

Senior Validation/Regulatory Affairs Associate

Senior Validation/Regulatory Affair Associate

Job Purpose and Scope:

The primary objective of this position is to facilitate Sydney based complementary manufacturer in their relevant processes and systems to comply with local regulatory requirements and relevant authority in Australia.

Core Job Responsibilities:

• Senior QA/Regulatory Affairs related activities.
• Provide regulatory input into premarket, post market, and business activities as required, respective to assigned portfolios.
• Review labelling, packaging, and promotional materials for compliance with regulatory standards.
• Coordinate / perform / assist with product registration process include research therapeutic functions of new products and prepare and submit ARTG listing application.
• Create templates for Quality and technical documentation and ensure compliance with GMP regulations
• Meet the requirementstoCode of GMP by complying with all relevant Quality policies and procedures to ensure the Quality objectives of the business are met.
• Establish and maintain specifications and standards for control of raw material; packaging and finished products.
• Manage/coordinate company quality system.
• Coordinate / perform / assist with product registration process include research therapeutic functions of new products and prepare and submit ARTG listing application.
• Support other departments on technical and quality issues especially Sales / Production / Operations departments.
• Maintain existing licenses and acquire required licenses/certificate as needed.
• Maintain the company MVP programs include carry out IQ/OQ/PQ, process validation and cleaning validations.

Knowledge / Education Required:

Minimum Bachelor of Science or Engineer or equivalent.

Experience Required:

Hand on experience required in Regulatory affairs to perform this job.

Must have been a quality with QA experience or Regulatory Affairs associate in complementary industry with minimum 2 years’ experience.

KnowledgeofAustralian Health AuthorityTGAregulationsa must with understanding of basic principles in HACCPpreferable.

Preference will be provided to candidates with previous experience in a complementary manufacturing facility.