Regulatory Affairs and Quality Assurance Associate

4 days ago

Sydney, New South Wales, Australia Caruso's Natural Health Full time
Regulatory Affairs and Quality Assurance AssociateRegulatory Affairs and Quality Assurance Associate

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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 and goal-driven company, committed to delivering natural 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…

Drive the development and continuous improvement of Caruso's Quality Management System, ensuring compliance with TGA, GMP, FSANZ, and other regulatory standards to deliver safe, high-quality complementary medicine products from concept to market.

What you will do….

  • Drive compliance with TGA, PIC/S GMP, Medsafe and NZ Dietary Supplement regulations
  • Review and approve product specifications, labels and listings across the product lifecycle
  • Own preparation and maintenance of product Listings in the TGA EBS
  • Approve marketing and promotional materials in line with the Therapeutic Goods Advertising Code
  • Lead audits, supplier qualifications and non-conformance resolution
  • Drive continuous improvement of the Quality Management System (QMS)
  • Investigate complaints, deviations and implement effective CAPAs
  • Build and maintain robust evidence packages to substantiate product claims
  • Monitor pharmacovigilance systems and escalate safety concerns
  • Stay ahead of regulatory changes and champion a culture of quality and compliance

What is on offer?

  • Join a collaborative, values-driven team culture with strong cross-functional support
  • Opportunity to shape quality assurance for a leading Australian brand
  • Work at the forefront of natural health innovation while upholding strict compliance
  • Professional growth through continuous learning and industry engagement
  • Competitive remuneration package, employee benefits and on-site facilities
  • Head office Based in Eastern Creek with secure onsite parking, close to M4 M7

To be successful in this role, you need to:

  • A degree in Pharmaceutical Science, Chemistry, Pharmacy, or related discipline
  • Minimum 3 years' experience in Quality Assurance and/or Regulatory Affairs within the TGA medicines sector
  • 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

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 charmaine@carusoshealth.com.au. For more information on our company and products, please see our website: www.carusosnaturalhealth.com.au

Seniority level
  • Seniority levelAssociate
Employment type
  • Employment typeFull-time
Job function
  • Job functionQuality Assurance, Legal, and Research
  • IndustriesRetail Health and Personal Care Products, Pharmaceutical Manufacturing, and Biotechnology Research

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