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Regulatory associate

Melbourne
Mentholatum Pty
Posted: 30 April
Offer description

Mentholatum Australasia is part of a global organisation that manufactures and markets high-quality healthcare products worldwide. Our portfolio spans topical pain relief, skin care, lip care, laxatives and nail care, with iconic brands including Deep Heat, Alpha Keri, Hada Labo Tokyo and Laxettes.

Our vision is simple: making people's lives healthier and happier. We value trust, integrity, collaboration, and being our best — and we're looking for someone who brings the same mindset to how they work every day.

About the role

Based in Scoresby, Victoria, this is a full-time role (with some flexibility in hours negotiable for the right candidate) conducted on site 5 days per week.

Reporting to the Senior Regulatory Associate, the Regulatory Associate will have three key areas of accountability:

* Provide regulatory strategy and guidance for new products, product changes, and market submissions
* Ensure compliance with ARTG requirements, label claims, and the Therapeutic Goods Advertising Code
* Supporting the strategic growth of Mentholatum Australasia by enabling timely and compliant product development and market access through a robust regulatory framework

Key responsibilities across a typical month include:

* Maintain product registrations, listings and regulatory records
* Support regulatory submissions, variations and changes
* Review product claims, labels, artworks and advertising for compliance
* Track submissions, approvals and correspondence
* Support claim substantiation and literature reviews
* Partner with teams across NPD, Quality and Marketing
* Liaise with Regulators and external stakeholders (e.g. TGA, AICIS, Medsafe, APCO)
* Stay across regulatory changes and contribute to continuous improvement

About you

To be successful in this role you will ideally have:

* A science-related qualification (chemistry, pharmacy or similar)
* Exposure to Regulatory Affairs (pharma, devices, cosmetics or FMCG)
* Working knowledge of AU/NZ regulatory frameworks
* Strong written communication and stakeholder skills
* A learning mindset and appetite to grow
* GMP or manufacturing exposure (desirable)

As part of a small but highly effective Quality & Regulatory team, you will contribute to our ongoing growth while enjoying the opportunity to grow your career through diverse on-the-job experience and access to mentoring and training.

If you are passionate about the commercial application of regulatory frameworks and looking for a role where you can make a real impact, we would love to hear from you. Apply now to join our team and help us Make People's Lives Healthier and Happier!

Your application will include the following questions:

* Which of the following statements best describes your right to work in Australia?
* How many years' experience do you have as a Regulatory Associate?
* Have you completed a qualification in pharmacy / pharmaceutical science?
* Have you completed a Good Manufacturing Practice (GMP) training course?
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