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:
List the primary tasks or activities this job performs
Senior 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 recent 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 current 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.
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📌 Senior Regulatory Affairs Associate New South Wales
🏢 Star Combo Australia
📍 New South Wales