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Avni Bell

@avnibell

Regulatory affairs professional at LabConnect who supported IND submissions and quality-controlled audit-ready documentation.

United States

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What I'm looking for

I’m eager to apply my QA expertise and regulatory knowledge to support global health product development and compliance.

At LabConnect, I supported the preparation and quality control of IND and regulatory submissions, contributing to accurate, compliant, audit-ready documentation. I managed document lifecycle tasks including version control, formatting, and signature collection.

At Zydus Research Centre, Zydus Lifesciences., I supported nonclinical IND submissions and 505(b)(2) applications, and worked as a GLP QA auditor on preclinical studies. I’m pursuing a Master of Science in Biomedical Regulatory Affairs at the University of Washington, with training in FDA and international requirements for drugs, medical devices, and biologics.

Experience

Work history, roles, and key accomplishments

Regulatory Documents Coordinator

LabConnect

Oct 2025 - Dec 2025 (2 months)

Supported preparation and quality control of IND and regulatory submissions, ensuring accuracy and compliance. Managed document lifecycle and streamlined workflows to enhance submission efficiency.

Regulatory Submissions IND FDA Guidance Documents ICH Guidelines Document Management Version Control Quality Control

Research Associate

Zydus Research Centre, Zydus Lifesciences

Apr 2020 - Aug 2021 (1 year 4 months)

Supported compilation and review of nonclinical data for IND submissions and contributed to 505(b)(2) applications. Led GLP QA audits for over 10 preclinical studies, ensuring compliance and data integrity.

Regulatory Affairs IND 505(B)(2)Bioequivalence SEND GLP QA auditing Toxicology DMPK Immunoassays COVID 19 Vaccinations Biosimilars

Senior Scientific Assistant

Zydus Research Centre, Zydus Lifesciences

Sep 2015 - Mar 2020 (4 years 6 months)

Applied quality management and compliance documentation principles to support regulatory readiness. Executed comprehensive QA activities including internal audits, vendor audits, and computer system validation.

Quality Management GLP GCLP Compliance GDP CAPA Change Control SOPs Internal Audit Supplier Audits CSV Regulatory Inspections

Education

Degrees, certifications, and relevant coursework

University of Washington

Master of Science, Biomedical Regulatory Affairs

Grade: 3.9/4.0

Activities and societies: Regulatory Affairs Fellowship at Fred Hutch Cancer Center; practicum project on regulatory strategy for automation of cytogenetic analysis using machine learning; capstone project on regulatory assessment of a medical device.

Pursuing a Master of Science in Biomedical Regulatory Affairs with a current GPA of 3.9/4.0, expected graduation in June 2026.