Regulatory Affairs Associate

About the Role

Join our Australia and New Zealand Regulatory Affairs team as a Regulatory Affairs Associate and develop your expertise in the regulatory landscape for innovative medical technologies. Collaborate closely with the ANZ Regulatory Affairs Manager and team to assist in preparing and submitting regulatory applications to the Therapeutic Goods Administration (TGA) in Australia and Medsafe in New Zealand. This role also involves maintaining product registrations and ensuring compliance with regulatory requirements. The position is located in Mascot, Sydney, reporting directly to the Regulatory Affairs Manager.

Key Responsibilities

• Assist in preparing and lodging regulatory submissions to TGA and Medsafe authorities.
• Manage and maintain current product registrations throughout their lifecycle.
• Support strategies related to the introduction of new products and changes to existing ones.
• Review marketing and promotional materials to ensure regulatory compliance.
• Maintain detailed and accurate regulatory documentation and records.
• Uphold commitment to patient safety and product quality by adhering to all quality policies and procedures.

Continuous Improvement and Digital Initiatives

• Identify and implement AI, automation, and digital tools to optimize regulatory processes.
• Promote a culture of continuous improvement by challenging existing workflows and recommending innovative solutions to enhance efficiency.

Cross-Functional Collaboration

• Engage with stakeholders across various departments, including commercial, quality, and operations teams, as well as global regulatory teams.
• Exemplify company values and demonstrate integrity while performing all responsibilities.

Essential Competencies

• Effective teamwork and collaboration to achieve team objectives.
• Strong communication skills and ability to build productive partnerships.
• Establish and maintain respectful, diverse, and inclusive relationships both internally and externally.
• Strong planning and execution skills to manage projects with clear outcomes and accountability.
• Effective verbal and written communication combined with active listening skills.
• A customer-centric approach to deliver quality solutions and services.
• Demonstrate courage by addressing issues proactively and advocating for improvements.

Experience and Skills

• Bachelor’s degree in science, pharmacy, engineering, or a related discipline is preferred.
• Prior exposure to regulatory affairs or quality roles in the pharmaceutical or medical device sectors is advantageous but not mandatory.
• Strong analytical thinking with a structured problem-solving approach.
• Excellent written and oral communication skills suitable for diverse stakeholders.
• Curiosity and eagerness for continuous learning and development opportunities.
• High attention to detail ensuring delivery of quality work.
• Collaborative mindset with ability to foster positive workplace relationships.
• Proficiency with Microsoft Office and familiarity with digital collaboration platforms is preferred.
• Interest in emerging technologies like Artificial Intelligence (AI) and enthusiasm for leveraging digital tools to enhance process efficiency.

Benefits

• Certified as a Great Place to Work for 2024 and 2025.
• Recognized among Best Workplaces for Women in 2024 and 2025.
• Access to inclusive Employee Resource Groups fostering diversity.
• Two wellbeing days awarded per year.
• Discounted health insurance options.
• Opportunity to purchase additional annual leave.
• Participation in the Employee Stock Purchase Plan.
• Available Employee Assistance Program for support.