Nutraceutical Regulatory Affairs Specialist

Pharmako Biotechnologies Pty; Sydney; On-site; AUD 75,000 - 105,000; Full time

Job summary

Pharmako Biotechnologies is a leading Australian manufacturer of nutraceutical products and is seeking a Regulatory Affairs Associate to join the team in Sydney. The role supports regulatory, compliance and product development across medicines, foods, cosmetics and related products.

Reporting to the Regulatory Affairs Manager, you will assist in submissions, dossiers, and regulatory maintenance while collaborating with R&D, Quality, Production and Marketing to ensure product lifecycle compliance

Qualifications

• Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Food Science, Nutrition, Biotechnology, Chemistry, Life Sciences, or a related discipline.
• Strong technical writing and document management capabilities.
• Knowledge of Australian regulatory frameworks (TGA, FSANZ, NICNAS/AICIS) and related international regulations.
• Experience preparing regulatory submissions, technical dossiers, specifications, or compliance documentation.
• Exposure to GMP, HACCP, ISO quality systems.
• Experience supporting regulatory inspections and audits.

Responsibilities

• Assist in preparation, compilation, and maintenance of regulatory submissions for therapeutic goods, foods, cosmetics, and related products.
• Support the development and maintenance of technical dossiers for raw materials and finished products.
• Conduct regulatory research and prepare assessments to support product development and commercialisation.
• Monitor regulatory changes and communicate impacts to stakeholders.
• Assist in preparing responses to regulatory authorities and customers.
• Support post-market compliance activities and regulatory maintenance.

Job description

Pharmako Biotechnologies is a leading Australian manufacturer of nutraceutical products and is seeking a Regulatory Affairs Associate to join the team in Sydney. The role supports regulatory, compliance and product development across medicines, foods, cosmetics and related products.

Reporting to the Regulatory Affairs Manager, you will assist in submissions, dossiers, and regulatory maintenance while collaborating with R&D, Quality, Production and Marketing to ensure product lifecycle compliance