PALAK JAIN

Proactive and aspiring regulatory affairs professional with a strong educational background in life sciences and a keen interest in ensuring compliance with regulatory standards. The blend of health science, law, and business in the work environment will enhance adaptability and strategic thinking abilities, ultimately leading to a more rewarding and challenging career within the esteemed organization.

FDA Compliance Program Analysis Project ,Boehringer Ingelheim, Toronto.

October – December 2023

Project Leader

• Leading a multidisciplinary team in conducting an in-depth analysis of the FDA's compliance program, with a focus on the CDRH revised
compliance program.
• Researching and analyzing key elements and related documents of the CDRH program to assess its impact on medical device manufacturers.
• Delivered a comprehensive presentation to faculty and industry professionals, highlighting key findings and recommendations.
• This project has already enhanced leadership, research, data analysis, and presentation skills, contributing to a deeper understanding of regulatory compliance in the healthcare sector.

Root Cause Analysis Project, Northeastern University, Toronto.

May, 2023

• Led a cross-functional team in conducting a comprehensive root cause analysis of 3 medical devices.
• Utilized the 5-Whys and Fishbone technique to identify key bottlenecks.
• Developed and presented a detailed report outlining the findings and recommended solutions.

Design and Development of Deodorizing footpad, H.K College of Pharmacy, Mumbai.

October, 2020

Relevant Coursework Completed: Awarded 2nd prize on presenting a thesis on Design and Development of Deodorizing footpad to the Mumbai University. To solve the problem of sweaty feet and smelling shoes due to long period of usage. Designed a deodorizing footpad, which not only absorbs sweat but also deodorizes the shoe and foot.

Production, Quality Control & Packaging Department, Pharmalink Laboratories, Mumbai.

May 2019- Aug 2019

• 3 Month Internship during 3rd year Bachelor in Pharmacy in Production, Quality Control and Packaging Department.
• Carried out quality control and quality assurance using QA/QC equipments.
• Prepared and maintained documentation of the whole process.