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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 environment
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Requirements
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- More than 3-5 + years of experience in an industry-related environment in Australia including Current 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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