Regulatory Data Analyst

Job Title: Regulatory Operations Data Analyst

Assignment Duration: 3+ Months (Initial contract through year-end; potential extension based on project scope and approval)

Location: Hybrid – North Chicago, IL 60064, 1 day remote (Friday)

Work Arrangement: Hybrid (North Chicago, IL – 4 days on-site, 1 day remote on Fridays)

Position Summary

We are seeking a detail-oriented Regulatory Operations Data Analyst to support our Global Submission Operations team. This role centers on evaluating, categorizing, and structuring high-volume Requests for Information (RFIs/IRs) and corresponding responses from global health authorities.

The ideal candidate bridges pharmaceutical domain expertise with practical data analysis skills. Rather than requiring advanced automation or software engineering, this position demands a solid baseline understanding of regulatory submissions, drug development concepts, and health authority communication patterns, paired with dependable, functional Excel capabilities.

Key Responsibilities

• Health Authority Request Evaluation: Review and analyze 900+ RFIs and agency responses across major global regulators (FDA, Health Canada, EMA/European agencies) covering 2025 through year-to-date.
• Content Categorization: Apply standardized operational criteria to classify inquiries, specifically differentiating between Data-Related Issues (requests for supplemental safety/efficacy data, data discrepancies) and Technical/Submission Issues (eCTD structure, missing documentation, improper document placement).
• Dataset Management & Maintenance: Systematically compile, clean, and organize classified findings into standardized tracking datasets using Microsoft Excel.
• Trend & Metric Generation: Segment and analyze regulatory data to identify recurring themes, operational bottlenecks, and submission trends.
• Baseline Reporting: Build foundational baseline datasets to support future cross-year health authority feedback comparisons and executive-level summary reporting.
• Independent Execution: Maintain strict data integrity and high attention to detail while managing assigned workflows with minimal oversight.

Qualifications & Requirements

Regulatory & Pharmaceutical Foundation (Critical):

• Prior operational or academic background in Regulatory Affairs, Regulatory Operations, Quality Assurance, or a closely related pharmaceutical discipline.
• Direct familiarity with health authority communication (RFIs/IRs), regulatory submissions, and life-sciences terminology.
• Candidates must be able to comprehend pharmaceutical product documentation without baseline regulatory onboarding.

Data Handling & Excel Proficiency:

• Strong working knowledge of core Microsoft Excel functions (sorting, filtering, structuring large datasets, and slicing metrics).
• Note: Advanced technical programming (VBA/macros, complex Power Query, automated dashboard development) is not required.

Education & Experience:

• Bachelor’s or Master’s degree in Regulatory Affairs, Life Sciences, or a related discipline combined with 1–3 years of hands-on industry experience; equivalent industry-specific experience will also be evaluated.
• Core Competencies: High analytical rigor, procedural accuracy, ability to interpret context-heavy documentation, and effective cross-functional communication.

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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.