Regulatory and Technical Affairs Associate

Regulatory and Technical Affairs Associate 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. 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 and Medsafe). 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. Support the maintenance of Pharmacovigilance requirements. Assist with Adverse Drug 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, Medsafe/New Zealand Dietary supplements and international markets as required. 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 Have 3+ years of demonstrated experience in a similar or equivalent role within a like business, together with a Degree in a relevant field of Science, Law or other discipline. Proven success working within an in‑house Regulatory, Scientific Affairs and Naturopathic department. Experience drafting policies and regulatory correspondence, critical analysis, procedure reviews and implementation. Display an in‑depth knowledge of regulatory requirements and standards of healthcare products within FMCG and Complementary medicines. If you believe you are the right fit for this role, please provide a cover letter outlining your suitability, demonstrating your experience and tell us your story. We look forward to hearing from you. Please email . For more information on our company and products, please see our website . Seniority level Mid‑Senior level Employment type Full‑time Job function / Industries Quality Assurance, Legal, Research; Retail Health and Personal Care Products, Pharmaceutical Manufacturing, Biotechnology Research. #J-18808-Ljbffr