As a Junior Regional Submissions Planner, you will have the opportunity to support one of the world’s most prestigious pharma companies. You will work within the MSD Global Regulatory Affairs and Clinical Safety (GRACS) organization, in the Regulatory Affairs Operations Regional department for Europe, the Middle East, and Africa [EMEA]). You will be part of a multicultural team helping develop and apply strategies to ensure regulatory compliance.
How will you make an impact?
Regulatory Submission Planning:
• Support other planners in reviewing and managing the complexity of planning, managing, tracking, assembling, and delivering regulatory content, to meet regulatory strategy, regulatory compliance, and informational needs of regional regulatory authority for simple submissions
• Project management including managing dynamic timelines, interacting, negotiating, and collaborating with global stakeholders under guidance from senior planners Manage Operations aspects of submission planning for assigned products under guidance from senior regional planners:
• Submission planning
• Document retrieval
• Submission creation
• Delivery to health authorities
Support Regulatory Submission of simple dossiers:
• Support the regulatory submission creation and the registration tracking of the company regulatory submission targets from a regulatory operational perspective for the assigned region
Are you a good fit?
• Degree in a Life Science related discipline
• 6-12months of experience in the regulatory operations area
• Good knowledge of MS Office tools (Word, Excel, and PowerPoint)
• Business fluency in English
• Experience in Regulatory Submissions and/or regulatory publishing;
• Experience in process development/process improvement (Lean/Sigma Green/Black belt);
• Experience in tool development (especially regarding project management/submission planning)