Senior Regulatory Affairs Associate

Star Combo Australia; Sydney; On-site; AUD 90,000 - 130,000; Full time

Job summary

Star Combo Australia is seeking a Senior Regulatory Affairs professional to guide compliance with Australian regulatory standards for Sydney-based operations. You will support premarket and postmarket activities, review labelling and packaging, and drive ARTG listings and GMP-compliant documentation.

The role requires hands-on regulatory experience, QA background in a manufacturing setting, and knowledge of TGA regulations.

Qualifications

• Hands-on experience in Regulatory affairs with at least 2 years in a related role.
• QA experience in a complementary manufacturing facility.
• Bachelor's degree in Science or Engineering or equivalent.
• Knowledge of Australian Health Authority TGA regulations.

Responsibilities

• Senior Regulatory Affairs related activities.
• Provide regulatory input into premarket, post market, and business activities as required.
• 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 requirements to Code 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.

Skills

Regulatory affairs

Quality Assurance

Education

Bachelor of Science or Engineer

Job description

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 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.