The Position Holder will need to dissect various processes / ways of working applied within Global Regulatory Affairs and assess the most logical and efficiency way in order to meet business and compliance needs, taking into account performance.
- Ensure that risks and quality processes and activities within Global Regulatory Affairs are adequately done, supported by appropriated and robust processes and that these processes (and/or associated procedural documents) clearly reflect the roles and responsibilities of the various groups within Global Regulatory Affairs;
- Manage and facilitate input from Global Regulatory Affairs stakeholders as well as external key stakeholders.
- Develop KPIs to assess the efficiency of the new processes/interfaces.
Experience : 2-5 years in the Pharmaceutical Industry in RA department or Project Management Environment
- Knowledge of regulatory affairs and a variety of regulatory submissions and processes
- Project management experience
- Risks management experience is a plus
- Quality Experience is a plus
- Coordination of audit and Capa follow up is a plus
- Business Continuity Plan experience is a plus
- Six Sigma certification (green belt or black belt) is a plus
- Good communication, presentation and influencing skills
- Fluent in English (written and oral)
- Good cultural awareness and negotiating with customer competencies
- Logical/process oriented approach
- Ability to conduct a stakeholder analysis
- Team player
- Indepent interaction, influence and leadership with teams to ensure teams keep on track and