Reporting and Solutions - Senior Specialist, Regulatory Affairs

Job Description

Senior Specialist – Submission Planning & Requirements Management

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 aSenior 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

• Supportdata quality management and reporting, including identification, analysis, and resolution of data quality issues.
• Develop and maintainPower Platform solutions (Power Apps, Power Automate, Dataverse) to support submission planning, forecasting, and demand management.
• Build and maintainPower BI reports and dashboards, providing actionable insights to planners, leadership, and downstream data consumers.
• Extract and prepare datasets in support ofanalysis, reporting, and data quality initiatives.
• Supportdata migration activities, including validation, reconciliation, and stakeholder issue resolution.
• Launch and managedata 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.
• Hands‑on experience with theMicrosoft Power Platform, ideally including Power Apps development.
• Experience developing reports and dashboards inPower BI.
• Strongdata analysis skills.
• Experience supportingstakeholder engagement, including requirements gathering and issue troubleshooting.
• Ability to work across teams in a regulated, matrixed environment.

Preferred Qualifications

• Experience inRegulatory Operations, including submission planning or related regulatory processes.
• Familiarity withdata 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.

What we offer:

• Exciting work in a great team, global projects, international environment
• Opportunity to learn and grow professionally within the company globally
• Hybrid working model, flexible role pattern
• Pension and health insurance contributions
• Internal reward system plus referral program
• 5weeks annual leave,5sick days,15days of certified sick leave paid above statutory requirements annually,40paid hours annually for volunteering activities,12weeks of parental contribution
• Cafeteria for tax free benefits according to your choice (meal vouchers, sport, culture, health, travel, etc.), Multisport Card
• Vodafone, Raiffeisen Bank, Foodora, and other discount programs
• Up-to-date laptop and iPhone
• Parking in the garage for drivers or showers for bikers
• Competitive salary, incentive pay, and many more

Additional location(s) Compensation Information:

Required Skills:

Preferred Skills:

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Current Contingent Workers applyHERE

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