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Regulatory Affairs Associates

2 weeks ago

Sydney, New South Wales, Australia Star Combo Australia Full time $80,000 - $120,000 per year

Regulatory Affairs 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. TGA Audit experience is essential.

Core Job Responsibilities:

List the primary tasks or activities this job performs

  • Provide regulatory input into premarket, postmarket, and business activities as required, respective to assigned portfolios.
  • Review labelling, packaging, and promotional materials for compliance with regulatory standards.
  • Create templates for Quality and technical documentation and ensure compliance with GMP regulations
  • Manage change notifications, license renewals, and annual reports
  • 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.
  • Develop and review SOPs, testing protocols, maintain regulatory SOPs and ensure compliance with industry standards.
  • Registration of new products
  • 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 level to perform this job.

Must have been Regulatory Affairs associate in pharma/complementary industry with minimum 3 years' experience. TGA audit experience is essential.

Knowledge of Australian Health Authority TGA regulations a must with understanding of basic principles in HACCP preferable.

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