Senior Specialist, Regulatory Affairs - Submission Planning & Reporting

About the role

The Submission Planning and Requirements Management (SPRM) team supports regulatory submission planning for Global Regulatory Affairs and Clinical Sciences through high-quality planning data, reporting and innovative solutions. This Senior Specialist role covers data quality, reporting and tool development, including Power Platform solutions, and partners with stakeholders to deliver high-quality data for downstream consumers.

Key responsibilities

• Support data quality management and reporting, including identifying, analysing and resolving data quality issues
• Develop and maintain Power Platform solutions (Power Apps, Power Automate, Dataverse) for submission planning, forecasting and demand management
• Build and maintain Power BI reports and dashboards for planners, leadership and downstream data consumers
• Extract and prepare datasets for analysis, reporting and data quality initiatives
• Support data migration, including validation, reconciliation and stakeholder issue resolution
• Launch and manage data quality initiatives with SME stakeholders
• Troubleshoot issues with existing tools and datasets and partner with submission planners and cross-functional teams to turn requirements into scalable data and reporting solutions

Required profile

• Bachelor's degree
• 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: regulatory operations experience, familiarity with data migration and system transformation, and comfort in an evolving digital landscape

Required skills

• Microsoft Power Platform (Power Apps, Power Automate, Dataverse)
• Power BI reporting and dashboards
• Data extraction, data quality assurance and data reconciliation
• Regulatory affairs and regulatory submissions

What we offer

• Global projects in an international environment, with professional growth opportunities
• Hybrid working model and flexible role pattern
• Pension and health insurance contributions
• Annual leave, 5 sick days, 15 days of certified sick leave, 40 paid hours for volunteering and 12 weeks of parental contribution
• Cafeteria with tax-free benefits, multisport card and Vodafone, Raiffeisen Bank and Foodora discounts
• Up-to-date laptop and iPhone, parking or showers
• Competitive salary, incentive pay and referral program