– Relevant University Degree in Science or related discipline
– Minimum 6 years of relevant Regulatory experience within the biopharmaceutical industry, including license maintenance, labelling and publishing, and of working in regulated markets
– General knowledge of drug development
– Good knowledge of the regulatory product maintenance process
– Strong project management skills
– Leadership skills, including experience leading multi-disciplinary project teams
Desirable Skills/Experience:
– Excellent English written and verbal communication skills
– Cultural awareness
– Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
– Proficiency with common project management (e.g., MS Project) and document management tools
– Ability to work independently and as part of a team
– Influencing and stakeholder management skills
– Ability to analyze problems and recommend actions
– Continuous Improvement and knowledge sharing focused
– Basic understanding of emerging technologies like AI, ML etc
– Demonstrate ability to use digital tools and solutions relevant to own work tasks to support productivity, collaboration and learning
– Work proactively to understand future needs and opportunities for digital transformation that improve the effectiveness and speed of core business processes and decision making.
