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Regulatory affairs & legal officer

Sydney
Number 8 bio
Posted: 12 February
Offer description

Overview

Number 8 Bio is a venture-capital-backed start-up on a path to making a significant climate impact. We collaborate with farmers to enhance agricultural sustainability while boosting productivity. Our first products are innovative feed additives designed to eliminate methane emissions from the world's 2.6 billion cattle and sheep.

Methane, a greenhouse gas responsible for approximately ~30% of climate change, is more potent and shorter-lived than carbon dioxide. Eliminating man-made methane emissions is one of the fastest ways to combat climate change and ensure a sustainable future.

Incubating within Macquarie University in Sydney, we are a team of passionate innovators in climate science and technology. We offer a dynamic, intellectual environment, flexible work hours, and the opportunity to make a real difference.

About Number 8 Bio

Number 8 Bio is a venture-capital-backed start-up on a path to making a significant climate impact. We collaborate with farmers to enhance agricultural sustainability while boosting productivity. Our first products are innovative feed additives designed to eliminate methane emissions from the world\'s 2.6 billion cattle and sheep.

Methane, a greenhouse gas responsible for approximately ~30% of climate change, is more potent and shorter-lived than carbon dioxide. Eliminating man-made methane emissions is one of the fastest ways to combat climate change and ensure a sustainable future.

Incubating within Macquarie University in Sydney, we are a team of passionate innovators in climate science and technology. We offer a dynamic, intellectual environment, flexible work hours, and the opportunity to make a real difference.

About the Role

The Legal & Regulatory Affairs Officer will lead Number 8 Bio's regulatory strategy and execution across key global markets while overseeing legal and compliance activities in Australia and New Zealand.

This role will play a pivotal part in enabling product registrations, strengthening compliance and ethics frameworks, and bringing animal health regulatory expertise in-house as the company moves into commercialisation and manufacturing scale-up.

This role can be based in Australia or performed remotely and may suit candidates with international regulatory experience.

Responsibilities
* Lead Number 8 Bio's global regulatory strategy and execution across priority markets, enabling timely product registrations and approvals.
* Prepare, coordinate and review regulatory submissions and technical dossiers, working closely with internal teams, external laboratories and partners.
* Manage regulatory interactions and approvals across key jurisdictions (e.g. APVMA, ACVM, EFSA).
* Review and oversee regulatory trial plans, study protocols and reports to ensure alignment with applicable standards and requirements.
* Partner with manufacturing and engineering teams to establish and maintain compliance with relevant quality and regulatory frameworks.
* Build and lead compliance, ethics and risk management programs as commercial operations and manufacturing scale.
* Provide in-house legal support across contracts, policies, governance and risk, coordinating external counsel for specialised matters as needed.
* Support grant applications and non-dilutive funding initiatives with regulatory and compliance expertise.
* Represent Number 8 Bio in regulatory, legal and industry forums, supporting advocacy and stakeholder engagement.
Qualifications & Skills

We encourage candidates from a variety of professional pathways to apply. You may be a strong fit if you bring many (not necessarily all) of the following:

* A degree in Regulatory Affairs, Animal or Veterinary Science, Pharmacy, Law or a related discipline - or equivalent professional experience
* Several years of experience in regulatory, compliance and/or legal roles, ideally within animal health, veterinary, pharmaceuticals, ag-biotech or life sciences
* Hands-on experience leading or contributing to successful regulatory submissions and approvals across complex regulatory environments
* Familiarity with regulatory trial requirements (e.g. safety, toxicology, pharmacokinetics, efficacy studies)
* Working knowledge of Australian and New Zealand regulatory frameworks, or demonstrated ability to quickly develop expertise in new jurisdictions
* Experience collaborating across multidisciplinary teams and managing projects or workstreams
Preferred (but not essential)
* Experience with manufacturing regulations for ag-vet chemicals or feed additives
* Exposure to intellectual property, patents or freedom-to-operate assessments
* Legal practising certificate
How you work
* Communicates clearly and thoughtfully, building trust with internal and external stakeholders
* Approaches complex problems with strong analytical skills and attention to detail
* Thinks long-term while managing near-term dependencies and execution risks
* Enjoys working collaboratively while being comfortable operating autonomously
* Motivated by purpose and impact, with an interest in climate, sustainability and agriculture
Why Join Us?
* Be part of a passionate team of innovators dedicated to improving agricultural productivity and reducing emissions
* Engage in meaningful work with significant global impact
* We offer competitive remuneration and employee share options
* Enjoy a flexible and dynamic work environment

Join us at Number 8 Bio and contribute to groundbreaking work in climate technology and sustainable agriculture. Apply now to be part of a team making a real impact.

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