Regulatory Affairs Associate

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 innovative nutraceutical, complementary medicine products. We are seeking a proactive Regulatory Affairs Associate to join our team. Located in a purpose built, TGA licensed facility on Sydney's Northern Beaches, we develop and manufacture products for customers across Australia and international markets.

We are seeking a motivated and detail orientedRegulatory Affairs Associateto join our expanding team. Reporting to theRegulatory Affairs Manager, this role will support the regulatory, compliance, and product development activities across complementary medicines, foods, cosmetics, and related healthcare products.

Qualifications and Experience

Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Food Science, Nutrition, Biotechnology, Chemistry, Life Sciences, or a related discipline.

Minimum 1-3 years' experience in Regulatory Affairs, Quality Assurance, Technical Services, Product Development, or a related role.

Experience working within a regulated environment, preferably pharmaceuticals, complementary medicines, foods, cosmetics, or medical devices.

Strong technical writing and document management capabilities.

Knowledge of Australian regulatory frameworks, including TGA, FSANZ, NICNAS/AICIS, or equivalent international regulations.

Experience preparing regulatory submissions, technical dossiers, specifications, or compliance documentation.

Familiarity with GMP, HACCP, ISO quality systems, or equivalent standards.

Exposure to customer audits, supplier qualification, or regulatory inspections.

Experience supporting international market access activities.

Tasks and Responsibilities

Regulatory Affairs & Compliance

Assist in the preparation, compilation, and maintenance of regulatory submissions and applications 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 regulatory assessments to support product development and commercialisation activities.

Monitor changes to regulatory requirements and communicate potential impacts to relevant stakeholders.

Assist in preparing technical correspondence and responses to regulatory authorities, customers, and business partners.

Support post market compliance activities, including product variations, updates, and regulatory maintenance.

Product Development Support

Work closely with Research & Development, Quality, Production, and Marketing teams to support new product development projects.

Conduct regulatory reviews of formulations, ingredients, labels, specifications, and claims.

Assist with product feasibility assessments and market access evaluations for Australia and international markets.

Support product scale up and commercial launch activities.

Assist in establishing, reviewing, and maintaining raw material, intermediate, and finished product specifications.

Quality Systems & Audits

Support the implementation and maintenance of regulatory and quality management systems.

Assist in coordinating customer, supplier, and certification audits.

Participate in the investigation and closure of audit findings, deviations, and corrective actions.

Ensure documentation is maintained in accordance with GMP and company procedures.

Support supplier qualification and technical document review activities.

Cross Functional Collaboration

Liaise with internal departments to ensure regulatory requirements are considered throughout the product lifecycle.

Coordinate collection and review of technical documentation from suppliers and customers.

Assist in the preparation of technical reports, compliance statements, and customer questionnaires.

Support continuous improvement initiatives across regulatory and quality functions.

Strong attention to detail and commitment to accuracy.

Excellent written and verbal communication skills.

Ability to interpret technical, scientific, and regulatory information.

Strong organisational, planning, and time management skills.

Ability to manage multiple projects and competing priorities.

Effective problem solving and analytical skills.

Proficiency in Microsoft Office applications, particularly Word, Excel, and PowerPoint.

Ability to work both independently and collaboratively within a cross-functional team.

Professional approach to stakeholder engagement and customer interactions.

Commitment to maintaining confidentiality and high ethical standards.

This position offers the opportunity to gain broad exposure to product development, regulatory submissions, quality systems, customer audits, and international market access activities. Applications from recent graduates with relevant qualifications and a strong interest in Regulatory Affairs are also encouraged to apply.

The successful candidate will work closely with internal departments, customers, suppliers, and regulatory authorities to ensure products are developed, manufactured, and maintained in compliance with applicable Australian and international regulatory requirements.