Senior Regulatory Associate

Mentholatum Australasia; City of Melbourne; On-site; AUD 110,000 - 160,000; Full time

Job summary

Mentholatum Australasia is seeking a Senior Regulatory Associate to take ownership of our Regulatory Affairs function and help shape how we maintain compliance and bring trusted healthcare products to market across Australia, New Zealand and selected international markets.

You will lead regulatory activities, develop strategies for lifecycle management and product registrations, review labeling and advertising materials, and provide clear guidance to cross-functional teams to support commercial

Qualifications

• Tertiary qualifications in Science, Pharmacy, Regulatory Affairs or a related discipline.
• Experience in the pharmaceutical, therapeutic goods, healthcare, medical device, cosmetics or consumer products sector.
• Strong working knowledge of Australian and New Zealand regulatory requirements, ideally including AUST L and/or AUST R products.
• Experience with product registrations, variations, labelling, advertising compliance, claims review and lifecycle management.

Responsibilities

• Lead regulatory activities across Australia, New Zealand and selected international markets.
• Develop and execute regulatory strategies to support product innovation and market growth.
• Review and approve labelling, advertising and technical communications.
• Monitor regulatory changes and translate them into practical business actions.
• Provide coaching and prioritisation support to the Regulatory Associate.
• Build strong relationships with internal stakeholders and regulatory authorities.

Skills

Regulatory affairs

Stakeholder management

Regulatory strategy

Problem solving

Communication

Education

Science/Pharmacy/Regulatory Affairs degree

Job description

About us

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.

We are seeking a Senior Regulatory Associate to take ownership of our Regulatory Affairs function and help shape how we maintain compliance, support innovation and bring trusted healthcare products to market.

About us

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.

We are seeking a Senior Regulatory Associate to take ownership of our Regulatory Affairs function and help shape how we maintain compliance, support innovation and bring trusted healthcare products to market.

About the role

This is a hands-on, influential role suited to a mid-career regulatory specialist who is ready to step into broader ownership, work across a diverse product portfolio and make a practical difference to the way regulatory advice supports business decisions.

Reporting to the Head of Quality, you will lead regulatory activities across Australia, New Zealand and selected international markets, including product registrations, variations, lifecycle management, labelling, advertising compliance, claims substantiation, New Product Development and market access support.

You will also coach and guide a Regulatory Associate, partner closely with teams across Quality, Commercial, Marketing, Supply Chain and Operations, and provide clear, risk-based advice that helps the business move forward with confidence.

In this role, you will:

• Lead and continuously improve regulatory processes, systems and ways of working.
• Develop and execute regulatory strategies that support product innovation, lifecycle management and market growth.
• Review and approve labelling, advertising, promotional material and technical communications.
• Monitor regulatory changes and translate them into practical business actions.
• Build strong relationships with internal stakeholders, regulatory authorities, industry bodies and external partners.
• Support APCO reporting, packaging sustainability obligations and related regulatory requirements.
• Provide coaching, guidance and prioritisation support to the Regulatory Associate.

About you

You are an experienced regulatory affairs professional who enjoys solving problems, building trusted relationships and helping good ideas progress in a compliant and commercially sensible way.

You may already be operating at a senior associate level, or you may be a capable regulatory specialist ready for a role where you can broaden your influence, mentor others and take greater ownership of strategic regulatory outcomes.

To be successful, you will bring:

• Tertiary qualifications in Science, Pharmacy, Regulatory Affairs or a related discipline.
• Experience in the pharmaceutical, therapeutic goods, healthcare, medical device, cosmetics or consumer products sector.
• Strong working knowledge of Australian and New Zealand regulatory requirements, ideally including AUST L and/or AUST R products.
• Experience with product registrations, variations, labelling, advertising compliance, claims review and lifecycle management.
• The ability to interpret complex requirements and communicate them clearly to non-regulatory stakeholders.
• A practical, solutions-focused mindset, with the judgement to balance compliance, risk and commercial priorities.
• A collaborative approach, personal accountability and a genuine commitment to doing work that improves outcomes for consumers.

If you are looking for a role where your regulatory expertise will be valued, your judgement will make a difference, and your work will contribute to trusted healthcare products used by people every day, we would love to hear from you.