Senior Regulatory Affairs Associate

A bit about us

Melrose Group is a progressive and innovative whole-body health and wellness company and has been a household name in natural and organic foods, therapeutic and health products for the last five decades. We have two brands within Melrose Group, comprising Melrose Health (www.melrosehealth.com.au) and Nu-Lax (www.nu-lax.com). We are driven to produce high quality and premium products so we can achieve our purpose – To inspire a healthier, happier you, naturally! We’re incredibly proud of this but there’s still a lot more work to do…. that’s where you come in! Let us provide you with more information.

What does the role involve

We have an exciting opportunity for a full time Senior Regulatory Affairs Associate to join our Regulatory team. This role supports the business in regulatory compliance for all Melrose Group products and processes in Australia and internationally.  You will be responsible for TGA, FSANZ and ACCC compliance as well as a number of other programs across our product range and our two manufacturing sites. This role will report to the Regulatory Affairs Manager of Melrose Group and is split between our head office in Mount Waverley and one of our Rowville manufacturing facilities.

What we need in the role

As a TGA-licensed company, we take immense pride in the quality of our products, our systems, and, above all, the calibre of our team members. If you possess exceptional attention to detail, a dedication to minimising risk and ensuring compliance, and are excited by the opportunity to learn while supporting multifunctional teams, we want to hear from you! The ideal candidate for this role is an adept communicator and boasts a comprehensive understanding of and experience in liaising with regulatory bodies such as the TGA, FSANZ, ACCC, and Medsafe standards in food and complementary medicine. A genuine passion for health and an unwavering commitment to continuous improvement are prerequisites, as you will thrive in our dynamic, fast-paced environment.

The team. 

You'll join our experienced and committed Regulatory team, which is dedicated to delivering exceptional support to help the business achieve its goals. As a key team member, you will collaborate closely with the operations and marketing teams, using your expertise to drive successful outcomes crucial to our business strategy.

What responsibilities form part of this role?

Working within the Regulatory team as well as the broader business, key responsibilities will include:

• Providing regulatory guidance for all products, both complementary medicine and food.
• Formulation and label reviews. 
• Completing and maintaining TGA listings.
• Assisting with permitted indications determinations.
• Developing claims evidence packages for complementary medicines.
• Reviewing and updating the business with regulatory updates.
• Supporting international market registrations of our products.
• Ensuring marketing content complies with the relevant food and TGA Codes.
• Liaising with regulatory bodies and consultants, and 
• Supporting the quality, R&D and marketing teams in regulatory aspects and projects.

Why you should work with us?

You will be joining a dedicated team with a fun and hardworking culture who loves what they do, you will also get access to all our amazing perks. 

• Flexible Work – we understand that there is life outside of work, which is why we are committed to providing a flexible work environment. Depending on your role this may mean the option to work hybrid – in the office and from home 
• Free products, staff allowance and enticing discounts on all our amazing products 
• We are united by a core set of values that we live and breathe each day – Permission to play, Be purpose-led, Think future act now, Play fair & as one, Make it happen and Communication is key. 
• Benefits program – Access to a number of health initiatives focusing on your Mind, Body, Soul, Occupational and Financial wellbeing. This includes things such as 3pm Friday finish, weekly meditations, paid birthday leave and employee recognition program 
• Employee Assistance Program - strictly confidential service for employees and their immediate families, which is available to support them through any personal or work matters that they might experience

Specific skills/qualifications needed

We are looking for an outstanding candidate with the following skills and experience:

• Degree qualifications in Science/Pharmaceutical/Food Science/Food Technology/ Law or relevant discipline
• 2-3 years’ experience in a Regulatory Affairs role in a TGA licenced business.
• Working with TGA and FSANZ regulatory requirements.
• Good Knowledge and experience in complementary medicines and food.
• Attention to detail and ability to produce high-quality documentation.
• Feel comfortable with ambiguity and thrive on providing creative solutions.
• Skilled in MS word and Excel.
• A high degree of personal accountability, including time management.
• Ability to coordinate projects and contribute to continuous improvement initiatives.

If you would like to join our team and be a part of our growing success story, please click on the apply link and send your resume AND cover letter. Alternatively, for a confidential discussion, please get in touch with Hayley Meaden on 0420 941 ***.