Regulatory Affairs & NPD Associate
Eucalyptus' mission is to deliver higher-touch, higher-quality healthcare to the world. We’re looking for a passionate Regulatory Affairs & NPD Associate to join our world-class New Product Development team, specialising in OTC Medicines, Complimentary Medicines, Food Products, Medical Devices, and Cosmeceuticals. The NPD team is responsible for researching, ideating, justifying, and developing the best personalised product solutions across our 4 brands that power our omnichannel distribution strategy.
As the Regulatory Affairs & NPD Associate, reporting to the Senior NPD manager, you’ll focus on:
- Work collaboratively with colleagues in cross-functional teams regarding research, claims evidence development, and EPD/variation updates relative to regulatory guidelines as well as regulatory interpretation.
- Critically appraise evidence to develop and substantiate claims according to the TGA, FSANZ, and/or ASEAN guidelines in line with project deliverable deadlines.
- Manage and engage our external regulatory consultant where necessary.
- Provide guidance & balanced risk assessments based on reviews of regulatory compliance & business strategy.
- Support on claims writing and evidence file creation.
- Proactively identify, correct and resolve compliance issues.
- Assist our legal team in responding to regulator post-market surveillance reviews and queries as required.
- Project manage regulatory activities supporting new product & existing product development launches, including managing ARTG listings, bulk specs, artwork compliance reviews, regulatory dossiers & review of marketing collateral in relation to product advertising
- Autonomously establish & refine various regulatory processes & best business practices to improve team efficiency & compliance.
- Provide project management support to the NPD team and throughput of EPD/NPD projects in line with the E2E process.
Resourceful - you can move mountains with only some smarts and a bit of elbow grease. “I can’t find it” isn’t in your vocabulary
Attentive to detail - You know that sometimes you can judge a book by its cover. You understand the role of quality as part of the product life-cycle and its importance
Customer obsessed - you understand and empathise with our diverse customer base; you relentlessly advocate for customers and build scalable systems that deliver real outcomes to them
Objective - you seek truth through data and use the best evidence to make decisions
Transparent - you challenge respectfully, share insights freely and own your mistakes
Resilient - you keep your cool when the kitchen starts to get a little hot (which is most days!)
A high achiever - you’ve probably been top of your class; this is the place to test yourself
Reliable - you’ll have big goals and lots of autonomy; we need to know you can handle it
Passionate - your energy to help people improve their health is infectious
You are the right candidate for this role if you:
- Have established experience in regulatory affairs in Australia for TGA listed medicines & FSANZ foods
- Familiarity with the TGA guidelines, GMP environments, Advertising Codes and FSANZ Code.
- Have a strong commercial lens & are able to inform on product risk & business strategy with this in mind
- Can work autonomously on various priorities & brands with competing priorities
- Demonstration of strong key stakeholder and project management skills, including New Product Development
Bonus points if you have:
- Qualification in relevant technical discipline (e.g. Naturopath, Nutritionist, Pharmacist)
- Regulatory exposure to cosmetics, TGA medical devices & consumer goods
- Experience in claims evidence development based on the TGA evidence guidelines
- Experience working in regulations across global markets, including the UK & EU.