Regulatory and Technical Affairs Associate

Caruso's Natural Health; Blacktown; On-site; AUD 90,000 - 120,000; Full time

Benefits offered by this job

Collaborative culture

Competitive pay

On-site parking

Head office NSW

Job summary

Caruso's Natural Health is seeking a Regulatory and Technical Affairs Associate to support compliance with TGA, FSANZ and related standards for our range of complementary medicines. You will guide regulatory submissions, maintain product listings, and ensure accurate documentation across all materials.

This is an in-house role at our NSW head office, involving collaboration with manufacturing, QA, and product development teams to sustain high quality and compliant product offerings for

Qualifications

• Minimum 3 years of demonstrated experience in a similar or equivalent role within a like business is essential.
• A Degree in a relevant field of Science, Pharmacy, Law or other related discipline
• Proven success working within an in-house Regulatory, Scientific Affairs and Naturopathic department is required
• Strong knowledge of GMP, QMS, and therapeutic goods regulatory frameworks
• Exceptional attention to detail, documentation and organisational skills
• Excellent communication skills, with the ability to collaborate across diverse teams
• A proactive, adaptable, and ethical approach with high levels of professionalism and integrity

Responsibilities

• Ensure all regulatory activities adhere to the requirements of relevant legislation and regulatory bodies TGA, GMP and PICs, FSANZ
• Maintain legislative and regulatory compliance of all products, including review and approval of Product Specifications, product labels, training materials, marketing, promotional and advertising materials
• Validate and maintain product Listings, and assist with responses to TGA post-market surveillance requirements
• Maintain an efficient, effective and transparent records management system for all contracts, emails, versions and submissions, evidence packs and dossiers
• Support the retention sample process, including the filing of retention samples and discarding of samples as they exceed mandated storage guidelines
• Assist with the Stability program as required and ensure ongoing stability and testing exists for all products within the requirements of TGA GMP/PICS code
• Liaise with manufacturers regarding Manufacturing, QC and GMP issues and escalating any matters affecting product quality, efficacy and saleability, or any other unresolved concerns
• Assist with product research and have input in new product development, including evidence collation, permitted indication, formulation and dosage substantiation
• Monitor and maintain pharmacovigilance systems and elevate safety concerns
• Assist with Adverse Drug Event Reporting
• Uphold a working knowledge of relevant regulations and legislations in the scope of complementary medicines and food products, per TGA, GMP and PICs, FSANZ
• Develop and maintain effective working relationships with internal and external stakeholders representing Caruso’s Natural Health in a confidential, ethical and professional manner

Skills

Regulatory affairs

GMP knowledge

Documentation

Communication skills

Education

Degree in Science/Pharmacy/Law

Job description

Caruso's Natural Health: A Proud Australian Family Business

Founded in June 1982, Caruso's Natural Health is a 100% Australian-owned family company dedicated to providing high-quality complementary medicines, including vitamins, minerals, and herbal supplements. Our products are distributed to over 3,000 pharmacies and health food stores across Australia.

At Caruso’s Natural Health, we pride ourselves on being an innovative, goal-driven company committed to delivering health solutions that empower individuals to lead healthier, happier lives. Our passion for health and customer satisfaction remains central to everything we do.

About the role…

The primary objective of the Regulatory and Technical Affairs Associate is to support ongoing compliance with all relevant regulatory requirements for Caruso’s Natural Health product range. You will ensure that the company’s products, services and processes adhere to the standards set by applicable regulatory bodies such as the Therapeutic Goods Administration (TGA), Medsafe and Food Standards Australia and New Zealand (FSANZ), whilst providing support to the New Product Development program, providing regulatory guidance, and evidence and claims substantiation.

What you’ll do….

• Ensure all regulatory activities adhere to the requirements of relevant legislation and regulatory bodies TGA, GMP and PICs, FSANZ
• Maintain legislative and regulatory compliance of all products, including review and approval of Product Specifications, product labels, training materials, marketing, promotional and advertising materials
• Validate and maintain product Listings, and assist with responses to TGA post-market surveillance requirements
• Maintain an efficient, effective and transparent records management system for all contracts, emails, versions and submissions, evidence packs and dossiers
• Support the retention sample process, including the filing of retention samples and discarding of samples as they exceed mandated storage guidelines
• Assist with the Stability program as required and ensure ongoing stability and testing exists for all products within the requirements of TGA GMP/PICS code
• Liaise with manufacturers regarding Manufacturing, QC and GMP issues and escalating any matters affecting product quality, efficacy and saleability, or any other unresolved concerns
• Assist with product research and have input in new product development, including evidence collation, permitted indication, formulation and dosage substantiation
• Monitor and maintain pharmacovigilance systems and elevate safety concerns
• Assist with Adverse Drug Event Reporting
• Uphold a working knowledge of relevant regulations and legislations in the scope of complementary medicines and food products, per TGA, GMP and PICs, FSANZ,
• Develop and maintain effective working relationships with internal and external stakeholders representing Caruso’s Natural Health in a confidential, ethical and professional manner

What’s on offer?

• Collaborative team culture
• Competitive remuneration package on offer
• Head office based in Eastern Creek, with Secure on-site parking
• Close to M4 M7
• Great employee benefits and on-site facilities

To be successful in this role, you need to:

• Minimum 3 years of demonstrated experience in a similar or equivalent role within a like business is essential,
• A Degree in a relevant field of Science, Pharmacy, Law or other related discipline
• Proven success working within an in-house Regulatory, Scientific Affairs and Naturopathic department is required
• Strong knowledge of GMP, QMS, and therapeutic goods regulatory frameworks
• Exceptional attention to detail, documentation and organisational skills
• Excellent communication skills, with the ability to collaborate across diverse teams
• A proactive, adaptable, and ethical approach with high levels of professionalism and integrity