Job Description

Senior Validation/Regulatory Affairs Associate n

Senior Validation/Regulatory Affair Associate

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Job Purpose and Scope:

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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.

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Core Job Responsibilities:

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

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Minimum Bachelor of Science or Engineer or equivalent.

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Experience Required:

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

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

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

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

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📌 Senior Validation/Regulatory Affairs Associate (Sydney)
🏢 Star Combo Australia
📍 Sydney