Quality Control Regulatory Affairs

Braganya Naivanai Rangabashyam

Boston, MA 857-***-**** ******************.*@************.*** LinkedIn Professional Summary

Regulatory Affairs graduate student at Northeastern University with hands-on experience in quality control and regulatory compliance. Currently assisting Cairn Diagnostics in filing a De Novo request for Class II reclassification of their GEBT device. Experienced in GMP, GCP, regulatory documentation, and gap analysis. Passionate about ensuring product safety and navigating complex regulatory pathways

Education

Northeastern University GPA – 3.91 Expected May 2026 Master of Science in Regulatory Affairs Boston, MA SRM Institute of Science and Technology GPA – 3.5 May 2024 Bachelor of Technology in Biotechnology Chennai, TN Skills

Regulatory Compilance: Quality Assurance and Control, Regulatory Compliance Strategy, Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Policy Development Technical Skills: Technical Writing, Project Management, Trello, 510k pathway, PMA, De Novo Request, Microsoft Office Suite (Excel, Word, PowerPoint)

Soft Skills: Exceptional Interpersonal Skills, Strong Organizational Skills, Problem Identification & Solution Creation, Verbal, Presentation and Communication Skills, Attention to Detail, Strong Analytical and Problem-Solving Abilities, Time Management, Proactive and Self-Directed Approach, Relationship Building and Maintenance Professional Experience

Cairn Diagnostics

Internship, Brentwood, USA January 2025 - Present

• Collaborated with Cairn Diagnostics to reclassify a gastric emptying breath test (GEBT) device from Class III to Class II under FDA regulations, optimizing regulatory strategy and cost efficiency.

• Developed a De Novo Request and provided cross-functional regulatory support, contributing to key documents such as the Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), Technical File, Post-Market Clinical Follow-up

(PMCF) Plan/Report, and Post-Market Surveillance (PMS) Plan/Report. Embreyo Seeds Pvt. Ltd.

Research Intern, Hyderabad, India June 2023 – July 2023

• Collaborated with the quality control team to assess seed quality in compliance with industrial regulations.

• Conducted detailed visual and instrumental analyses of seed samples, documenting results to support product quality control and regulatory submissions.

• Streamlined quality control processes, reducing assessment time by 10%.

• Supported the preparation of regulatory dossiers for seed quality certification. Sai Mirra Innopharm Pvt. Ltd.

Research Intern, Chennai, India July 2022 – August 2023

• Collaborated with the Quality control team in analyzing and documenting test results on various pharmaceutical products to ensure safety and quality compliance with regulatory requirements.

• Gained a comprehensive understanding of the drug development process from preclinical studies to post marketing surveillance.

Projects

Development and Evaluation of Molecular Imprinted Polymer-Based Paper Device for Sensing Perchlorate in Water Samples (Academic Research Project)

• Developed a systematic approach to create the device, optimizing experimental conditions for maximum sensitivity in perchlorate detection.

• Employed various analytical techniques to evaluate sensor performance, including calibration curves and sensitivity tests.

• Conducted qualitative assessments of device functionality and applicability, ensuring regulatory compliance for potential deployment.

• Enhanced device sensitivity by 15% through optimized experimental conditions.

• Documented project findings in compliance with academic and regulatory standards. Lamivudine 100 mg Tablet Preparation and Microbial Testing

• Assisted in the formulation and quality control process for Lamivudine 100 mg tablets, ensuring compliance with Standard Operating Procedures (SOPs).

• Conducted microbial testing to meet regulatory standards, identifying and mitigating potential contamination risks.

• Documented testing procedures and results, collaborating with the Quality Control (QC) team for final product approval.

• Monitored tablet preparation steps to ensure compliance with Good Manufacturing Practices (GMP).

• Identified and resolved a microbial contamination issue, ensuring product safety.

• Contributed to achieving 100% compliance with GMP standards during tablet preparation. Certifications

• Good Clinical Practice (GCP) – Clinical Trials Network (CTN), National Institute on Drug Abuse (NIDA) February 2025

• Introduction to Good Manufacturing Practices (GMP) – Pharmuni October 2024

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