Job Description
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Project Execution
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Previous experience working in industry in support of Global and/or local Regulatory teams
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Strong knowledge of post-authorization lifecycle maintenance procedures
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Use of document management tools (internal systems) and external platforms
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Prepare, organize and coordinate local specific documentation
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Ability to manage/coordinate impact assessments for technical changes impacting marketing authorization
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Stay updated on local regulatory requirements, and guidelines
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Maintain regulatory compliance and support HA inspections
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Works effectively within a team setting
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Requirements
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More than 3-5 + years of experience in an industry-related environment in Australia including New Zealand
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Project management knowledge
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Client-focused approach to work
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Results orientation
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Teamwork and collaboration skills
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Excellent interpersonal and intercultural communication skills, both written and verbal
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Critical thinking and problem-solving skills
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Proficiency in local language and extensive working knowledge of the English language
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Minimum of a Bachelor's Degree in a Scientific or Technical Discipline
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Core Competencies
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Demonstrates expertise in project execution and regulatory compliance, with a strong focus on post-authorization lifecycle maintenance and local regulatory requirements. Proficient in managing documentation and impact assessments while fostering teamwork and effective communication.
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Highest-signal resume keywords
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Project Management Knowledge
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Regulatory Compliance
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Post-Authorization Lifecycle Maintenance
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Intercultural Communication Skills
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Impact Assessment Coordination
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ATS Optimization Keywords
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Hard Skills
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Project Execution
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Regulatory Knowledge
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Impact Assessment Management
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Document Management
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Technical Change Coordination
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Soft Skills
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Client-Focused Approach
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Results Orientation
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Teamwork
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Critical Thinking
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Problem-Solving
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Certifications & Qualifications
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Bachelor's Degree in a Scientific or Technical Discipline
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Industry Keywords
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Regulatory Teams
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Local Regulatory Requirements
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HA Inspections
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Australia
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New Zealand
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Tools & Technologies
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Document Management Tools
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Internal Systems
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External Platforms
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#J-*****-Ljbffr

📌 Senior Regulatory Affairs Associate - Ra Generalist (Sydney)
🏢 Jobtailor
📍 Sydney