Senior Specialist – Submission Planning & Requirements Management

Job Description

Senior Specialist – Submission Planning & Requirements Management

Location: Costa Rica or Prague

Function: GRACS OPS RIIM - Submission Planning & Requirements Management (SPRM)

Role Overview

The Submission Planning and Requirements Management (SPRM) team manages the submission planning capability for Global Regulatory Affairs and Clinical Sciences, supporting regulatory submission planning through robust, high‑quality planning data, reporting, and innovative solutions.

We are seeking a Senior Specialist to support data quality, reporting, and tool development across our submission planning ecosystem. This role will play a key part in developing Power Platform solutions, supporting reporting and analytics, and partnering with stakeholders to ensure high‑quality data for downstream consumers across GRACS.

Key Responsibilities

• Support data quality management and reporting , including identification, analysis, and resolution of data quality issues.
• Develop and maintain Power Platform solutions (Power Apps, Power Automate, Dataverse) to support submission planning, forecasting, and demand management.
• Build and maintain Power BI reports and dashboards , providing actionable insights to planners, leadership, and downstream data consumers.
• Extract and prepare datasets in support of analysis, reporting, and data quality initiatives .
• Support data migration activities , including validation, reconciliation, and stakeholder issue resolution.
• Launch and manage data quality initiatives , engaging SME stakeholders for review, validation, and continuous improvement.
• Troubleshoot and resolve issues related to existing tools and datasets, working closely with key stakeholders.
• Partner with submission planners and cross‑functional teams to understand requirements and translate them into scalable data and reporting solutions.

Required Qualifications

• Bachelor’s degree.
• Minimun 5 years of experience in Regulatory Operations , including submission planning or related regulatory processes.
• Hands‑on experience with the Microsoft Power Platform , ideally including Power Apps development.
• Experience developing reports and dashboards in Power BI .
• Strong data analysis skills .
• Experience supporting stakeholder engagement , including requirements gathering and issue troubleshooting.
• Ability to work across teams in a regulated, matrixed environment.

Preferred Qualifications

• Familiarity with data migration efforts and system transformations.
• Experience supporting tools and data sets used by downstream reporting consumers.
• Comfort working in an evolving digital landscape with a focus on continuous improvement and innovation.

Required Skills:

Academic Quality Improvement Program (AQIP), Clinical Development, Compliance Monitoring, Data Migrations, Data Quality, Data Quality Control, Global Regulatory Submissions, Interdisciplinary Collaboration, Interpersonal Relationships, Medical Affairs, Medical Knowledge, Pharmaceutical Medical Affairs, Pharmaceutical Quality Assurance, Project Risk Assessments, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Intelligence, Regulatory Submissions, Requirements Management, Situational Leadership, Stakeholder Engagement, Stakeholder Management, Technical Documentation Management, Troubleshooting

Preferred Skills:

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