Own and develop regulatory strategy across significant programs or portfolios, ensuring alignment with business objectives and regulatory requirementsProvide leadership on major regulatory decisions, including authority engagement models, submission strategies, and risk mitigation approachesLead the planning and execution of high-impact regulatory submissions, coordinating cross-functional teams and ensuring compliance with regulatory requirementsDevelop and implement long-range development and lifecycle management plans that optimize regulatory pathways and commercial outcomesCollaborate with clinical, scientific, and commercial teams to align regulatory strategy with development timelines and market opportunitiesMonitor regulatory landscape changes and provide strategic recommendations to adapt development and submission approachesKey RequirementsSignificant 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.SkillsProject management knowledgeClient-focused approach to workResults orientationTeamwork and collaboration skillsConsulting skillsExcellent interpersonal and intercultural communication skills, both written and verbalCritical thinking and problem-solving skillsProficiency in local language and extensive working knowledge of the English languageKnowledge and ExperienceAt least 7+ years of experience in an industry-related environment with a deep Australia regulatory expertiseEducationMinimum of a Bachelor's Degree in a Scientific or related area of study#LI-REMOTE
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📌 Regulatory Affairs Consultant - Fsp (Brisbane)
🏢 Parexel
📍 Brisbane