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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 Key Requirements Significant Regulatory Affairs experience supporting Australian product development and lifecycle management.
Proven experience leading or supporting HA interactions and regulatory procedures.
Solid 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.
Skills: 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 Knowledge and Experience: At least 7+ years of experience in an industry-related environment with a deep Australia regulatory expertise Education: Minimum of a Bachelor's Degree in a Scientific or related area of study