Regulatory Affairs Consultant

• Own and develop regulatory strategy across significant programs or portfolios, ensuring alignment with business objectives and regulatory requirements
• Provide leadership on major regulatory decisions, including authority engagement models, submission strategies, and risk mitigation approaches
• Lead the planning and execution of high-impact regulatory submissions, coordinating cross-functional teams and ensuring compliance with regulatory requirements
• Develop and implement long-range development and lifecycle management plans that optimize regulatory pathways and commercial outcomes
• Collaborate with clinical, scientific, and commercial teams to align regulatory strategy with development timelines and market opportunities
• Monitor regulatory landscape changes and provide strategic recommendations to adapt development and submission approaches

• Significant Regulatory Affairs experience supporting Australian product development and lifecycle management
• Proven experience leading or supporting HA interactions and regulatory procedures
• Strong understanding of Marketing Authorisation Applications (MAAs) and CTD/eCTD dossier requirements
• Experience preparing and reviewing regulatory documentation, including Module 1 content and health authority briefing materials
• Demonstrated expertise in regulatory strategy development, dossier review, and health authority engagement
• Excellent project leadership, stakeholder management, and communication skills
• Ability to manage multiple regulatory priorities while delivering high-quality outcomes in a fast-paced environment
• Project management knowledge
• Client-focused approach to work
• Results orientation
• Teamwork and collaboration skills
• Consulting skills
• Excellent interpersonal and intercultural communication skills, both written and verbal
• Critical thinking and problem-solving skills
• Proficiency in local language and extensive working knowledge of the English language
• At least 7+ years of experience in an industry-related environment with deep Australia regulatory expertise
• Minimum of a Bachelor’s Degree in a Scientific or related area of study