Mukta Garge
About Mukta Garge
Mukta Garge is a Regulatory Affairs Associate with extensive experience in regulatory submissions and compliance. She has worked for several pharmaceutical companies, including Perrigo API and Unichem Laboratories, and currently serves at Cronos Group in Toronto, Canada.
Work at Cronos Group
Mukta Garge has been employed as a Regulatory Affairs Associate at Cronos Group since 2020. In this role, she is responsible for managing regulatory submissions and ensuring compliance with industry standards. Her work involves coordinating and submitting regulatory documents to various global markets, including the United States, Europe, and Canada. Mukta's expertise in regulatory affairs contributes to the company's ability to navigate complex regulatory environments.
Previous Experience in Regulatory Affairs
Prior to her current position, Mukta Garge worked at several organizations in the regulatory affairs sector. She served as a Regulatory Affairs Executive at Unichem Laboratories Limited from 2017 to 2019, where she focused on regulatory compliance in the Mumbai area. Before that, she was a Regulatory Affairs Assistant at Perrigo API from 2015 to 2017. Her career began with an apprenticeship at Perrigo API in 2015, which lasted four months.
Education and Expertise
Mukta Garge holds a Bachelor's degree in Pharmacy from Vivekanand Education Society's College of Pharmacy, where she studied from 2009 to 2013. She furthered her education at the University of Mumbai, obtaining a Master of Pharmacy in Medicinal and Pharmaceutical Chemistry from 2013 to 2015. Her educational background provides a strong foundation for her skills in regulatory affairs, including expertise in compiling and submitting eCTD submissions to various regulatory agencies.
Regulatory Submissions and Global Markets
Mukta Garge has significant experience in regulatory submissions, particularly in compiling and submitting eCTD submissions to agencies such as the USFDA, EDQM, Health Canada, PMDA in Japan, and ANVISA in Brazil. She is skilled in responding to Chemistry, Manufacturing, and Controls (CMC) queries, Complete Response Letters, and information requests. Her ability to coordinate and submit regulatory submissions to global markets is a key aspect of her professional expertise.