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 prospects
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.
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 rapid-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 workplace with a deep Australia regulatory expertise
Education
Minimum of a Bachelor's Degree in a Scientific or related area of study
LI-REMOTE