Quality Assurance Regulatory Affairs

MEGHA

SUMMARY

Graduate student pursuing an MS in Regulatory Affairs at Northeastern University, Toronto, with 2.8+ years of hands-on experience in biochemistry, analytical development, and regulatory compliance. Expertise in method development, biosimilar analysis, and quality assurance. Seeking a part-time opportunity to leverage strong analytical, communication, and teamwork skills in a Canadian work environment, while gaining valuable industry experience. SKILLS

Multitasking & Time Management

Strong Communication & Interpersonal Skills

Attention to Detail & Organization

Quality Control & Assurance

Microsoft Office Suite (Excel, Word, PowerPoint)

Teamwork & Adaptability

Regulatory Documentation

Data Analysis & Reporting

Ipca Laboratories Pvt. Ltd. — Junior Research Associate February 2022 - November 2023

Led method development and qualification for biosimilar analysis using advanced techniques such as ProA, SEC, CEX, Peptide Mapping, SEC-MALS, Solo VPe, and BET. Managed multiple concurrent projects, ensuring timely and accurate data integrity, contributing to successful product development.

Trained new hires on laboratory techniques (HPLC/UPLC) and ensured compliance with regulatory standards (GLP).

Supported critical stability studies, contributing to the development of quality biopharmaceutical products.

+1-647-***-**** • *****.********@*****.***

EXPERIENCE

Ipca Laboratories Pvt. Ltd. — Trainee

March 2021 - January 2022

Assisted in laboratory operations, ensuring compliance with regulatory standards (GLP, GMP).

Supported senior research associates in method development, data analysis, and documentation.

Gained hands-on experience in laboratory testing, method qualification, and data collection. Meticulously documented procedures and maintained accurate records in line with regulatory requirements.

EDUCATION

Master of Science in Regulatory Affairs

Northeastern University, Toronto — 2025 - Present

Specialization: Biopharmaceuticals

Master of Science in Biochemistry

St. Aloysius College, Mangalore, India — 2018 - 2020 Bachelor of Science in Biochemistry, Chemistry, & Zoology St. Aloysius College, Mangalore, India — 2015 - 2018 ADDITIONAL ACTIVITIES

Languages

English, Hindi, Malayalam

Certifications

Data Management for Clinical Research, Vanderbilt University Awards/Activities

Student Resource Person - 2019 National Level Workshop Event Head, Program Drafting Committee - 2018 National Level Fest "Imprints

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