Regulatory Affairs Product Development

Lipi Thakkar

Chicago, IL ***** 617-***-**** ************@*****.*** https://www.linkedin.com/in/lipi-thakkar-419306221/ PROFESSIONAL SUMMARY

To leverage my experience in regulatory submissions, new product development, and compliance with national and international regulations to support the growth and success of innovative pharmaceuticals and medical devices as a Regulatory Affairs Specialist.

EDUCATION

Northeastern University, Boston, MA

Master of Science in Regulatory Affairs

Relevant Courses: Regulatory Writing, eCTD, FDA Pharma Regulations, Strategic Compliance, Human Experimentation, Project Management

May 2024

Dharmsinh Desai University, Nadiad, Gujarat

Bachelor of Pharmacy

May 2021

PROFESSIONAL EXPERIENCES

Formulation Co-op Intern

Omega Therapeutics, Boston, MA January 2023- June 2023

• Independently conducted screenings of 20+ lipid nanoparticles using novel lipids for optimization in both in-vitro and in-vivo studies.

• Performed LNP characterizations, increasing the efficiency of lipid nanoparticles to be induced in in-vivo by 30%.

• Maintained thorough documentation for all experiments using electronic lab notebooks that culminated the dates, cells used, process and organs that were transfected.

• Led an independent research project involving collaboration with 5 legal and regulatory experts, reviewing over 50 scientific publications and 10 patents where I got familiar with research websites.

• Produced a 15-page comprehensive report that informed team decisions and strategic direction to supervisor and the formulation team.

• Summarized and presented research findings to the board members and R&D team at the conclusion of the internship. Submission of new protocol to IND April 2022

• Prepared cover letter and reviewed study protocols for clinical trials.

• Compiled clinical reports and regulatory documents, emphasizing the importance of track changes in clinical trial documentation. Type-B Pre- IND Meeting Request B Form for Losartan Potassium February 2022

• Designed a document explaining the meeting purpose and outcomes with FDA.

• Listed critical questions and highlighted clinical trial details showcasing understanding of clinical trial process. Due Diligence Letter September 2021

• Drafted a comprehensive letter for a hypothetical IND submission scenario.

• Covered key topics: ethics committee correspondence, research data, audit reports, SOPs, and financial information. SKILLS AND EXPERTISE

Regulatory Skills:

• Knowledge of national and international regulations (FDA, EU, MHLW, TGA).

• Preparing and submitting hypothetical documentation for marketing approvals.

• Development of regulatory strategies for new product development.

• Ensuring adherence to FDA regulations, ICH guidelines, and local requirements.

• Knowledge of regulatory forms for FDA submissions related to clinical trials. Technical Skills

• Strong computer skills: MS Office, Adobe Acrobat.

• Understanding of product labeling requirements and standards. Soft Skills

• Strong organizational and time management skills.

• Excellent written and verbal communication.

• Advanced ability for independent work, teamwork, and decision.

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