Regulatory Affairs Specialist - Remote

Overview

The Regulatory Affairs Specialist plays a crucial role in ensuring internal and external regulatory compliance for the manufacture, importation, and supply of the entire animal health product range in Australia and New Zealand.

In Short

• Permanent full-time opportunity based in Sydney.
• Responsible for regulatory submissions to authorities like APVMA, ACVM, and DAFF.
• Manage compliance processes, including artwork changes and marketing materials.
• Provide regulatory input for change control processes.
• Assist in pharmacovigilance responsibilities if applicable.
• Requires a graduate or post-graduate degree in a relevant biological science field.
• Minimum 5 years of experience in a related industry.
• Experience in the animal health or pharmaceutical manufacturing industry is beneficial.
• Strong negotiation, communication, and organizational skills are essential.
• Ability to work collaboratively in a team setting.

Requirements

• Graduate or post-graduate degree in biological science.
• 5+ years of experience in regulatory affairs.
• Familiarity with Australian and New Zealand regulatory systems.
• Excellent negotiation and influencing skills.
• Strong written and verbal communication skills.
• Organizational skills and analytical problem-solving abilities.
• Ability to work across diverse projects and stakeholders.
• Experience in animal health or pharmaceutical manufacturing is a plus.
• Ability to work autonomously while being part of a team.
• Willingness to embrace diversity and inclusion in the workplace.

Benefits

• Work autonomously with support from a leading global organization.
• Opportunities for professional development and upskilling.
• Collaborative team environment with like-minded individuals.
• Commitment to diversity and inclusion in the workplace.
• Ethical integrity and an inspiring mission in global healthcare.