Regulatory Operations Data Analyst – Pharmaceutical

HYBRID North Chicago IL

1 day remote (Friday)

Pay: $34hr -$39/hr

Required Qualifications

• 1–3 years of relevant experience, preferably within pharmaceutical, biotech, medical device, cosmetic, food, or another regulated industry.
• Advanced Microsoft Excel skills – candidates should be comfortable organizing, analyzing, manipulating, and summarizing large datasets.
• Strong data analysis, data integrity, and attention-to-detail skills.
• Experience developing metrics, KPIs, dashboards, trend reports, or leadership reporting.
• Strong analytical and problem-solving skills with the ability to identify patterns and trends in data.
• Ability to work independently, manage priorities, and deliver accurate work with minimal supervision.
• Strong written/verbal communication and stakeholder-management skills.
• High school diploma/equivalent required; college degree preferred.

Highly Preferred

• Regulatory Affairs or Regulatory Operations experience.
• Experience analyzing regulatory or Health Authority data.
• Exposure to Health Authority correspondence, RFIs, regulatory submissions, or regulatory information management.
• Pharmaceutical/life-sciences experience.
• Process Improvement / Operational Excellence experience.
• Experience translating complex datasets into business insights and executive/leadership-level reporting.

Job Description:

We are seeking a detail-oriented Regulatory Operations / Data Analyst to support a high-visibility pharmaceutical regulatory initiative focused on analyzing and trending Health Authority Requests for Information (RFIs).

This role is ideal for someone who combines Regulatory Affairs/Regulatory Operations knowledge with advanced Excel and strong data-analysis skills. You will review a large volume of global and regional Health Authority requests, categorize regulatory data, identify recurring themes and trends, and develop metrics that can be used for leadership reporting and future regulatory process improvement.

Key Responsibilities

• Review and analyze 900+ Health Authority RFIs from global and regional regulatory agencies.
• Categorize regulatory requests using established criteria and ensure consistent, accurate classification.
• Compile and maintain a standardized regulatory tracking dataset with a strong focus on data quality and integrity.
• Analyze regulatory data to identify recurring themes, trends, patterns, and areas of opportunity.
• Develop metrics, KPIs, summaries, and trend analyses for leadership reporting.
• Translate large datasets into clear, actionable insights that support business and regulatory decision-making.
• Establish baseline metrics for comparison against future Health Authority feedback.
• Identify opportunities for process improvement and operational excellence.
• Work independently with minimal supervision while collaborating with cross-functional stakeholders.