Regional Submission Planner Associate Specialist

About the role

The Regional Submission Planner Associate Specialist works within the Global Regulatory Affairs and Clinical Safety (GRACS) organization, in the Regional Regulatory Operations (RRO) department, supporting regional planning activities for the EU and EEMEA region and others as needed. The role provides operational and administrative support to Regional Submission Planners so that regulatory submissions are planned, tracked and executed efficiently and compliantly. It is an entry-level position based in Prague.

Key responsibilities

• Support Regional Submission Planners with day-to-day planning and operational activities.
• Maintain and update regulatory planning systems, databases, trackers and repositories, and perform quality control reviews of planning data, timelines, submission records and documentation.
• Prepare routine planning reports, metrics, dashboards and status updates, and maintain planning documentation, meeting materials and action trackers.
• Monitor submission milestones and track deliverables against timelines, and assist with registration tracking.
• Support submission readiness and process improvement initiatives, escalating data discrepancies and system issues to experienced planners.

Required profile

• Bachelor's degree or equivalent experience in life sciences, pharmacy, regulatory affairs, business or a related field.
• Entry-level profile; an internship, apprenticeship or up to 1 year of experience in the pharmaceutical industry, regulatory affairs, project coordination or a regulated environment is desirable.
• Experience with project plans, timelines, tracking tools or data management is an advantage.

Required skills

• Familiarity with Microsoft 365 applications such as Outlook, Excel, PowerPoint, Teams and SharePoint.
• Ability to work in a matrix, multicultural, cross-functional environment and to learn new processes and systems quickly.
• Interest in regulatory affairs, submission planning and continuous improvement.