Reporting and Solutions - Senior Specialist, Regulatory Affairs

Regulatory Jobs; Upper Gwynedd Township (Montgomery County); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Hybrid work model

Pension and health insurance

Paid time off

Referral program

Latest tech equipment

Job summary

Regulatory Jobs in the United States is seeking a Senior Specialist to support data quality, reporting and tool development across our submission planning ecosystem. You will help develop Power Platform solutions, support reporting and analytics, and collaborate with stakeholders to ensure high-quality data for downstream consumers.

The role emphasizes building Power BI reports and dashboards, data extraction, and data migration activities within a regulated global environment.

Qualifications

• Bachelor’s degree in a relevant field.
• Hands-on experience with the Microsoft Power Platform, 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.

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.

Skills

Power Platform

Power Apps

Power BI

Data analysis

Stakeholder engagement

Regulated environment

Education

Bachelor's degree

Tools

Dataverse

Job description

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 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.
• 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

• Experience in Regulatory Operations, including submission planning or related regulatory processes.
• 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.

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
• 5 weeks annual leave, 5 sick days, 15 days of certified sick leave paid above statutory requirements annually, 40 paid hours annually for volunteering activities, 12 weeks 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:

Dashboard Reporting, Data Analysis Tools, Data Extraction, Data Management, Data Quality Assurance, Data Quality Control, Data Reconciliation, Data Reporting, Detail-Oriented, Drug Regulatory Affairs, Pharmaceutical Regulatory Affairs, Project Management, Quality Reporting, Regulatory Affairs Management, Regulatory Compliance, Regulatory Documents, Regulatory Operations, Regulatory Processes, Regulatory Strategy Development, Regulatory Submissions, Reporting Tools

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship: No

Travel Requirements: No Travel Required

Flexible Work Arrangements: Not Applicable

Shift: Not Indicated

Valid Driving License: No

Hazardous Material(s): NA

Job Posting End Date: 11/21/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.