7d ago , from Illawarra Mercury Job Board
Welcome to H&S;, a global leader in wellness brands, creating innovative products that make happiness simple. We champion wellness and elevate lives by prioritising the well-being of our customers.
We manage 300 international brands that have positively impacted the lives of over 50 million people worldwide. Our commitment to excellence is reflected in every aspect of our operations, from our dedicated R&D; team that drives innovation to our state-of-the-art manufacturing facilities that ensure superior product quality. By maintaining a robust, owned distribution network, we guarantee stringent control from upstream to downstream, allowing us to deliver truly prime offerings. Whether through iconic products, pioneering category leaders or timeless heritage brands, our mission is to enhance lives globally. We are devoted to delivering superior value and inspiring a future where happiness and wellness are the cornerstones of everyday life.
As part of the Regulatory Affairs team, this role is primarily responsible for supporting product compliance with legal, statutory, industry and corporate requirements related to the regulation of healthcare products in Australia.
Regulatory Affairs Associate
Develop and implement regulatory strategies aligned with business objectives and market requirements.
Provide regulatory support and advice for current product development (NPD), existing product changes, product classification, formulation compliance, and market access across Australia, North America,



and other international markets.
Prepare, submit, and manage regulatory applications for complementary medicines, foods, cosmetics, and other FMCG products.
Review and maintain regulatory documentation to ensure compliance with applicable regulatory requirements, identifying gaps and supporting timely resolution.
Review finished product and raw material specifications to ensure compliance with quality standards and regulatory requirements.
Ensure product labels, packaging artwork, and product information meet regulatory requirements.
Maintain regulatory records, databases, submissions, and change control documentation.
Work closely with R&D;, QA, brand, and cross-functional teams to manage regulatory matters and respond to regulatory enquiries from authorities such as TGA and FSANZ.
Support post-market compliance activities, product assessments, and regulatory audits when required.
Key Skills & Experience
Bachelor's degree or higher in Chemistry, Microbiology, Biotechnology, Pharmaceutical Sciences, Engineering or related field.
Minimum 2- 3 years of experience in pharmaceutical manufacturing.
Strong understanding of PIC/S GMP and TGA regulatory requirements.
Proven experience in specifications, documentation, audits, and validation activities.
Ability to work cross-functionally and manage competing priorities.
Target-oriented with a high level of integrity and professionalism.
Excellent written and verbal communication skills
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📌 Regulatory Affairs Associate (New South Wales)
🏢 HandS Global
📍 New South Wales