- Project Execution
- Previous experience working in industry in support of Global and/or local Regulatory teams
- Robust knowledge of post-authorization lifecycle maintenance procedures
- Use of document management tools (internal systems) and external platforms
- Prepare, organize and coordinate local specific documentation
- Ability to manage/coordinate impact assessments for technical changes impacting marketing authorization
- Stay updated on local regulatory requirements, and guidelines
- Maintain regulatory compliance and support HA inspections
- Works effectively within a team environment
Requirements
- More than 3-5 + years of experience in an industry-related environment in Australia including New Zealand
- Project management knowledge
- Client-focused approach to work
- Results orientation
- Teamwork and collaboration 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
- Minimum of a Bachelor's Degree in a Scientific or Technical Discipline
Core Competencies
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.