- The Regulatory Process Manager will be acting as project manager for the driving of specific process or procedural document developments and the updating within Global Regulatory Affairs (GRA) of Standard Operating Procedure (SOP) or Work Instruction in collaboration with owners and stakeholders.
- He/She will also participate to the development/maintenance of GRA Demand and Capacity Management systems, and KPI related to departmental performance.
- The Position Holder will need to dissect various processes / ways of working applied within GRA and assess the most logical and efficiency way in order to meet business and compliance needs, taking into account performance.
- Ensure that E2E GRA submission processes being developed/re-engineered are adequate, appropriate 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 Subject Matter Experts (SMEs) into the generation of written procedures and processes;
- Develop KPIs to assess the efficiency of the new processes/interfaces.
- Knowledge of regulatory affairs and a variety of regulatory submissions and processes
- Project management experience
- Six Sigma certification (green belt or black belt) is a plus Experience
- 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 deliver to commitments
- Good adaptability skills