Job Title

Caruso''s Natural Health: A Proud Australian Family BusinessFounded 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 and 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 roleThe 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 doEnsure 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 materialsValidate and maintain product Listings, and assist with responses to TGA post-market surveillance requirementsMaintain an efficient, effective and transparent records management system for all contracts, emails, versions and submissions, evidence packs and dossiersSupport the retention sample process, including the filing of retention samples and discarding of samples as they exceed mandated storage guidelinesAssist with the Stability program as required and ensure ongoing stability and testing exists for all products within the requirements of TGA GMP/PICS codeLiaise with manufacturers regarding Manufacturing, QC and GMP issues and escalating any matters affecting product quality, efficacy and saleability, or any other unresolved concernsAssist with product research and have input in new product development, including evidence collation, permitted indication, formulation and dosage substantiationSupport the maintenance of Pharmacovigilance requirementsAssist with Adverse Drug ReportingUphold 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 requiredDevelop and maintain effective working relationships with internal and external stakeholders representing Caruso''s Natural Health in a confidential, ethical and professional mannerWhat''s on offerCollaborative team cultureCompetitive remuneration package on offerHead office based in Eastern Creek, with Secure on-site parkingClose to M4 M7Great employee benefits and on-site facilitiesTo be successful in this role, you need3+ years of demonstrated experience in a similar or equivalent role within a like business is essential, together with a Degree in a relevant field of Science, Law or other disciplineProven success working within an in-house Regulatory, Scientific Affairs and Naturopathic department is requiredExperience drafting policies and regulatory correspondence, critical analysis, procedure reviews and implementationDisplay an in-depth knowledge of regulatory requirements and standards of healthcare products within FMCG and Complementary medicinesIf 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 [email protected]. For more information on our company and products, please see our website: www.carusosnaturalhealth.com.auRecruitment for this position will commence in mid-January.We kindly ask recruitment agencies to respect our recruitment process. At this stage, we are not accepting unsolicited resumes or candidate profiles, and we will be managing this recruitment internally.All recruitment activity is centrally coordinated through our Human Resources team. We ask that agencies please not contact other team members directly. Should we require agency support, we will reach out to our preferred partners proactively.Thank you for your understanding and for respecting our process and our people.#J-18808-Ljbffr