Senior Regulatory Affairs Associate

Troy Laboratories; Blacktown; On-site; AUD 120,000 - 190,000; Full time

Job summary

TROY Laboratories, an Australian-owned veterinary pharmaceutical company, is seeking a senior Regulatory Affairs professional to lead complex registrations across Australia, New Zealand and export markets. You will drive regulatory strategy, oversee submissions, and engage with regulators while supporting portfolio growth and ongoing compliance.

In this senior role you will mentor junior team members, contribute to capability development, and collaborate with Quality, Product Development,

Qualifications

• Experience leading regulatory submissions across multiple markets.
• Strong knowledge of APVMA legislation and registration processes.
• Ability to balance regulatory compliance with business objectives.

Responsibilities

• Lead preparation and maintenance of regulatory dossiers for Australia, NZ and export markets.
• Develop regulatory strategies for registrations, variations and lifecycle management.
• Coordinate inputs from internal and external stakeholders to submissions.
• Conduct regulatory impact assessments for product and manufacturing changes.
• Provide regulatory advice to cross-functional teams and ensure compliance.
• Monitor regulatory developments and manage relationships with authorities.

Skills

Regulatory strategy

Submission leadership

Stakeholder engagement

Technical writing

Project management

Regulatory compliance

Education

Degree in Science / Veterinary Science / Pharmacy

Job description

TROY Laboratories is an Australian-owned company dedicated to the manufacture of high-quality veterinary pharmaceuticals. With a legacy spanning over 60 years, TROY is trusted by veterinarians and farmers for its commitment to animal health, product innovation, quality, and cost competitiveness. Every stage, from product development to delivery, reflects this dedication.

The Opportunity

Reporting to the Regulatory Affairs Manager, you will lead complex registration and lifecycle management activities across Australia, New Zealand and export markets.

This is a senior technical role that combines regulatory strategy, submission leadership, stakeholder engagement and hands-on regulatory expertise. You will work closely with Quality, Product Development, Commercial, Supply Chain and Manufacturing teams to support new product registrations, portfolio growth and ongoing compliance across TROY's veterinary pharmaceutical portfolio.

As a senior member of the Regulatory Affairs team, you will provide expert regulatory advice, manage complex submissions, support regulatory decision-making and contribute to the continuous development of regulatory capability across the business.

Key Responsibilities

• Lead the preparation, submission and maintenance of regulatory dossiers across Australia, New Zealand and export markets.
• Develop regulatory strategies supporting new registrations, variations, renewals and lifecycle management activities.
• Lead responses to regulatory authority questions and coordinate technical inputs from internal and external stakeholders.
• Conduct regulatory impact assessments for product, manufacturing, quality and business changes.
• Provide regulatory advice to cross-functional project teams, including Product Development, Quality, Commercial and Supply Chain.
• Ensure ongoing compliance with relevant legislation, guidelines and regulatory requirements.
• Review product labels, packaging and promotional materials to ensure regulatory compliance.
• Monitor regulatory developments and assess their impact on TROY's portfolio and business objectives.
• Build and maintain effective relationships with regulatory authorities, industry bodies and key stakeholders.
• Support international registration activities and export market compliance requirements.
• Mentor junior team members and contribute to continuous improvement initiatives.
• Act as delegate for the Regulatory Affairs Manager when required.

About You

You are a confident regulatory professional with strong technical expertise and a demonstrated ability to influence outcomes across a complex stakeholder environment.

You combine sound regulatory judgement with a practical approach to balancing regulatory compliance and business objectives.

You will ideally bring

• A degree in Science, Veterinary Science, Pharmacy or a related discipline.
• Significant Regulatory Affairs experience within the pharmaceutical, veterinary pharmaceutical, animal health, agricultural chemical or healthcare sectors.
• Strong knowledge of APVMA legislation, regulatory frameworks and registration processes.
• Demonstrated experience managing complex regulatory submissions and product lifecycle activities.
• Experience preparing technical responses and interacting with regulatory authorities.
• Excellent written communication and technical writing skills.
• Strong project management, organisational and prioritisation skills.
• The ability to build trusted relationships with regulators and internal stakeholders.
• Commercial awareness and the ability to balance regulatory compliance with business objectives.
• Experience with international veterinary medicine registrations and export markets will be highly regarded.

Our Culture:

We believe that diversity of thought, background, and experience drives innovation. Our team is a tapestry of passionate individuals who thrive on challenge, support one another, and never lose sight of our shared purpose: Enabling a world where animals can thrive. We celebrate curiosity, integrity, and adaptability, and we welcome all voices. Here, you will find an environment in which your ideas are heard, and your impact is recognised.

Applicants must have the right to work in Australia.