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 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:

• Required Skills:

• 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

• Preferred Skills:

• Current Employees apply HERE

• Current Contingent Workers apply HERE

• Search Firm Representatives Please Read Carefully

• Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

• 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:

• 11/14/2026*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.