Open to opportunities

Nazish Faizan

@nazishfaizan

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Clinical research professional driving compliance, quality, and audit readiness.

United States

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What I'm looking for

I seek roles where I can drive compliance and quality improvements, lead audit readiness, collaborate cross-functionally, and apply regulatory expertise to strengthen clinical operations and documentation practices.

I am a clinical research and healthcare administration professional with PharmD and an M.S. in Pharmaceutical Sciences, bringing 10+ years of experience in regulatory compliance, quality oversight, and patient-facing operations. I have supported site activation, sponsor communications, and audit readiness under ICH-GCP/FDA/EMA standards while maintaining strict HIPAA/PHI practices and accurate documentation in eSource/eBinder and EMR/EHR systems.

My experience spans QA/QC, CAPA leadership, SOP development, FT-IR methodology creation, and regulatory documentation for global standards. I collaborate cross-functionally to strengthen site and laboratory compliance, prepare teams for inspections, and implement risk-mitigation strategies that improve process excellence and documentation integrity.

Experience

Work history, roles, and key accomplishments

Quality Assurance and Clinical Excellence Coordinator

DM Clinical Research

Mar 2024 - Jul 2025 (1 year 4 months)

Led SIV reviews and site readiness assessments under ICH-GCP, strengthened audit readiness and documentation accuracy, and coordinated patient engagement while maintaining HIPAA-compliant eSource/eBinder records.

ICH GCP HIPAA ESource EBinder (CRIO Florence SOP QMD Updates Sponsor Liaison

QC Compliance – Raw Materials Administration

Regeneron Pharmaceuticals

Oct 2022 - Jan 2024 (1 year 3 months)

Developed SOPs and FT-IR methodologies for biologic material identification, built an internal spectral library, and led CAPA/change control activities supporting Part 11 and FDA audit readiness.

FTIR SOP Development Part 11 Compliance CAPA Change Control LIMS Documentation Management

Senior Regulatory Affairs Specialist

NCI Pharmaceuticals

Oct 2016 - Feb 2020 (3 years 4 months)

Prepared regulatory documentation aligned with FDA, EMA, ICH and DRAP standards, supported change management and SOP readiness, and coordinated with R&D and quality for internal audit preparedness.

Regulatory Submissions Change Management Internal Audit DRAP Compliance

Diabetes Care Specialist II

The Diabetes Center

Jun 2012 - Jun 2015 (3 years)

Delivered physician training on diabetes therapies, led community educational outreach to promote rational drug use, and supported safe prescribing practices.

Diabetes Education Patient Engagement

Education

Degrees, certifications, and relevant coursework

Albany College of Pharmacy and Health Sciences

Master of Science, Pharmaceutical Sciences

2022 - 2025

M.S. in Pharmaceutical Sciences with a capstone on the impact of nanotechnology on antibody-conjugated nanoparticles, completed coursework and research between Jan 2022 and May 2025.

University of the Punjab

Doctor of Pharmacy, Pharmacy

2007 - 2013

Doctor of Pharmacy program completed at the University of the Punjab from Jan 2007 to Jan 2013 with coursework and clinical training in pharmacy practice.