Regulatory And Technical Affairs Associate

vor 3 Wochen


Sydney, Österreich Caruso'S Natural Health Vollzeit

Regulatory and Technical Affairs AssociateNatural Therapies & Alternative Medicine (Healthcare & Medical)Full timeCaruso's Natural Health: A Proud Australian Family BusinessSince our beginnings in June 1982, Caruso's Natural Health has been on a heartfelt mission to enhance the well-being of Australians.
As a 100% Australian-owned family company, we take immense pride in delivering premium complementary medicines—including vitamins, minerals, and herbal supplements—to over 3,000 pharmacies and health food stores across the nation.We are more than a brand—we are a legacy of trust, innovation, and commitment to natural health.
At Caruso's Natural Health, every product we create reflects our dedication to empowering individuals to live vibrant, healthier lives.
This passion for health and customer satisfaction drives every decision we make, every product we craft, and every solution we provide.About the role….As a Regulatory and Technical Affairs Associate, you will play a vital role in safeguarding the integrity of our products and the trust our customers place in us.
Your primary mission will be to ensure that the Caruso's Natural Health product range adheres to all regulatory standards, including those set by the Therapeutic Goods Administration (TGA), Medsafe, and Food Standards Australia and New Zealand (FSANZ).You'll be at the forefront of compliance, offering expert guidance and substantiating evidence and claims.
Additionally, you will provide critical support to our New Product Development program, helping to bring innovative health solutions to life while maintaining the high standards that define Caruso's.What you'll do….Ensure all regulatory activities strictly adhere to the requirements of relevant legislation and regulatory bodies, including TGA, GMP, PICs, FSANZ, and Medsafe.Maintain full legislative and regulatory compliance for all products, including reviewing and approving product specifications, product labels, training materials, and marketing and promotional materials.Validate and maintain product listings, and provide timely support in responding to TGA post-market surveillance requirements.Implement and oversee an efficient, transparent records management system for contracts, emails, document versions, submissions, evidence packs, and dossiers.Manage the retention sample process, including proper filing and the safe discarding of samples once they exceed mandated storage guidelines.Establish and monitor stability studies as required, ensuring an ongoing stability program and testing that comply with the TGA GMP/PICs code.Collaborate with manufacturers to address issues related to manufacturing, quality control (QC), and GMP.
Escalate any concerns affecting product quality, efficacy, saleability, or other unresolved matters.Support product research and contribute to new product development by assisting with evidence collation, permitted indications, formulation, and dosage substantiation.Ensure compliance with pharmacovigilance requirements and provide assistance with adverse drug reporting.Maintain a comprehensive understanding of relevant regulations and legislation, particularly within the scope of complementary medicines and food products, covering TGA, GMP, PICs, FSANZ, Medsafe, New Zealand dietary supplements, and international markets.Develop and nurture strong working relationships with internal and external stakeholders, representing Caruso's Natural Health with confidentiality, integrity, and professionalism at all times.What's on offer?Collaborative team culture.Competitive remuneration package on offer.Head office Based in Eastern Creek, Secure on-site parking.Close to M4 M7.Great employee benefits and on-site facilities.To be successful in this role, you need to:3+ 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 discipline.Proven success working within an in-house Regulatory, Scientific Affairs and Naturopathic department is required.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: www.carusosnaturalhealth.com.au.#J-18808-Ljbffr



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