Regulatory Inspector Resume Example

Senior Regulatory Compliance Inspector · BioGenRx Pharmaceuticals

Boston, MA · 2020 - Present

• Led over 50 internal and external audits of manufacturing facilities and contract laboratories, identifying critical non-conformances and guiding corrective action plans that reduced major deviations by 25%.
• Managed a portfolio of 15+ complex deviation investigations, utilizing root cause analysis techniques to implement effective CAPAs and prevent recurrence, improving quality metrics by 18%.
• Provided expert guidance on FDA 483 responses and warning letter remediation, contributing to 100% successful closure of three high-priority regulatory observations.
• Developed and delivered GxP training programs to cross-functional teams, increasing departmental understanding of regulatory requirements by 30% as measured by post-training assessments.
• Supported the successful filing of 5 new drug applications (NDAs) and 12 investigational new drug (IND) applications by ensuring data integrity and regulatory compliance across all submissions.

Regulatory Affairs Specialist · CurePath Biotech

Cambridge, MA · 2017 - 2020

• Assisted in preparation and execution of regulatory inspections (FDA, EMA), resulting in zero critical findings during two major facility inspections.
• Reviewed and approved over 200 quality system documents, including SOPs, batch records, and validation protocols, ensuring adherence to GxP and internal quality standards.
• Managed the lifecycle of 500+ change controls and deviations within the electronic Quality Management System (eQMS), improving process efficiency by 15%.
• Conducted gap analyses against current regulatory requirements (e.g., ICH Q9, Q10) for existing processes, leading to the implementation of 10 key procedural updates.
• Collaborated with R&D and manufacturing teams to ensure regulatory compliance for product development stages, contributing to the timely progression of 3 preclinical drug candidates.

Master of Science in Pharmaceutical Sciences · Tufts University

Medford, MA · 2016 - 2017

• Specialized in Pharmaceutical Manufacturing and Quality Assurance.
• Completed a capstone project on the impact of FDA 21 CFR Part 11 on data integrity in sterile drug manufacturing.
• Achieved a GPA of 3.8/4.0.

Bachelor of Science in Chemistry · University of Massachusetts Boston

Boston, MA · 2012 - 2016

• Graduated Cum Laude, recognized for academic excellence in organic and analytical chemistry.
• Conducted undergraduate research in spectroscopic analysis of novel compounds, presenting findings at two university symposiums.
• Developed strong laboratory skills including HPLC, GC, and mass spectrometry.

Quality Control Analyst · Abbott Laboratories

Lake Bluff, IL · 2018 - 2021

• Performed over 1,200 analytical tests on raw materials, in-process, and finished pharmaceutical products to ensure compliance with cGMP and internal specifications.
• Reduced testing turnaround time by 15% through optimization of sample preparation and instrument calibration procedures.
• Identified and investigated 70+ out-of-specification (OOS) results, contributing to a 10% reduction in product deviations.
• Maintained meticulous laboratory documentation, ensuring audit readiness for FDA and internal quality inspections.

Regulatory Affairs Specialist · Smithers

Northbrook, IL · 2021 - 2023

• Assisted in preparing and reviewing regulatory submissions for medical devices and consumer products, achieving a 98% approval rate on initial applications.
• Conducted gap analyses against ISO 13485 and FDA 21 CFR Part 820 for client quality management systems, identifying critical non-conformances.
• Developed and delivered internal training modules on new regulatory guidelines, enhancing team understanding by 25%.
• Managed and tracked over 50 client regulatory projects, ensuring timely completion and adherence to deadlines.

Regulatory Compliance Inspector · Thermo Fisher Scientific

Rockford, IL · 2023 - Present

• Conducts scheduled and unscheduled inspections of manufacturing facilities and research laboratories to ensure compliance with FDA, ISO, and internal quality standards.
• Identified and documented 30+ critical non-conformances within the first year, leading to a 20% improvement in corrective and preventive action (CAPA) implementation efficiency.
• Authored comprehensive inspection reports and collaborated with departmental heads to facilitate the timely resolution of compliance issues, reducing potential audit findings by 18%.
• Participates in cross-functional teams to review and update standard operating procedures (SOPs) in alignment with evolving regulatory requirements.
• Provided training to over 50 new employees on current Good Manufacturing Practices (cGMP) and quality control documentation best practices.

Bachelor of Science in Chemistry · University of Illinois at Urbana-Champaign

Urbana, IL · 2014 - 2018

• Graduated Magna Cum Laude with a GPA of 3.8/4.0
• Completed capstone research project on environmental chemical analysis techniques
• Relevant coursework: Analytical Chemistry, Organic Chemistry, Biochemistry, Instrumental Analysis