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:

11/21/2026 *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.