Biomera is a health and wellness business focused on developing and bringing high-quality products to market, including our KUCI brand.
As we continue to grow our product portfolio and expand into new markets, we are looking for an experienced Senior Regulatory Affairs Specialist to take ownership of regulatory affairs across the business.
This is a hands‐on role for someone who understands the Australian regulatory environment and can confidently navigate TGA, complementary medicines and FSANZ requirements, while also supporting product development and future international market opportunities.
About the Role
The Senior Regulatory Affairs Specialist will provide regulatory expertise across Biomera and KUCI's product portfolio, supporting products from concept and formulation through to launch and ongoing compliance.
The role will work closely with Product Development, R&D;, Science, Quality and Marketing to ensure products and supporting materials meet applicable regulatory requirements.
The primary focus will be Australian regulatory affairs, particularly TGA-regulated complementary medicines, with international regulatory experience highly regarded.
Key Responsibilities
Provide senior regulatory advice across Biomera and KUCI's product portfolio.
Manage regulatory requirements for TGA-listed complementary medicines, including new product listings and ongoing maintenance.
Respond to the TGA if required
Assess product formulations, ingredients and dosage forms against applicable regulatory requirements.
Review and provide regulatory approval of product labels, packaging, claims, advertising and marketing materials.
Prepare, review and maintain regulatory documentation and supporting evidence.
Interpret TGA legislation, guidelines and regulatory updates and communicate their impact to the business.
Provide regulatory input throughout new product development, from initial formulation through to commercial launch.
Assess the regulatory status and suitability of new ingredients and formulations.
Provide advice on product claims and claims substantiation, including the supporting scientific evidence required.




Maintain a strong working knowledge of FSANZ requirements and provide advice where products or ingredients fall within the food regulatory framework.
Support regulatory compliance across the product lifecycle.
Maintain regulatory registers, databases and documentation.
Monitor changes to Australian regulatory requirements and proactively identify potential impacts on the business.
Work collaboratively with Quality and Manufacturing to ensure regulatory requirements are incorporated into product specifications and manufacturing processes.
Respond to regulatory queries from customers, suppliers, distributors and internal stakeholders.
Support regulatory submissions and market‐entry activities for international markets.
Work with external regulatory consultants, distributors and other partners where required.
International Regulatory Affairs
International experience is highly desirable but not essential.
Experience in one or more of the following markets would be particularly valuable:
South Korea
United States
United Kingdom
China
Experience may include:
International product registrations or listings
Market‐entry requirements
International labelling and claims
Working with local regulatory authorities
Working with international regulatory consultants or distributors
Adapting Australian products for international markets
About You
You are an experienced regulatory professional who can operate independently, provide practical advice and confidently work across multiple projects.
5+ years' experience in Regulatory Affairs, preferably within complementary medicines, nutraceuticals, probiotics, supplements, food, consumer health or a related regulated industry.
Strong practical knowledge of TGA requirements and the Australian complementary medicines framework.




Demonstrated experience with TGA-listed products and regulatory maintenance.
Strong understanding of formulations, ingredients, product classification, claims and labelling.
Working knowledge of FSANZ and Australian food regulatory requirements.
Experience interpreting legislation, regulatory guidelines and standards and translating these into practical business advice.
Experience supporting products through new product development and commercialisation.
Strong attention to detail and excellent documentation skills.
Ability to independently manage regulatory projects, priorities and deadlines.
Strong communication skills and the ability to work effectively with technical and non-technical stakeholders.
Highly Desirable
Experience working with probiotic products.
Understanding of probiotic strains and strain‐specific regulatory considerations.
International regulatory experience.
Experience with South Korea, USA, UK and/or China.
Experience working with international distributors or regulatory consultants.
Experience in claims substantiation and scientific evidence.
Experience working within a GMP manufacturing setting.
Experience across both complementary medicines and food/supplement regulatory frameworks.
Qualifications
A relevant tertiary qualification in one of the following would be highly regarded:
Regulatory Affairs
Pharmacy
Pharmaceutical Science
Food Science
Biotechnology
Science
Health Science
Or another relevant discipline.
Equivalent industry experience will also be considered.
Why Join Biomera?
This is an opportunity to join a growing health and wellness business where you will have genuine influence over the regulatory direction of the business.
You will work across product development, regulatory affairs and commercialisation, rather than operating purely as a compliance function.
The role will provide exposure to both Australian and international regulatory markets, with the opportunity to help shape the regulatory framework as Biomera and KUCI continue to grow.
Location: Melbourne-based preferred / Hybrid
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📌 Senior Regulatory Affairs Specialist (Melbourne)
🏢 Biomera Biotics
📍 Melbourne