MU

Megasari Utami

Head Of Regulatory Affairs Of Combiphar Group at COMBIPHAR

Megasari Utami has a diverse work experience spanning various roles in different companies. megasari began their career in 2004 as an Analyst in the Analytical Lab at PT Indospec Prima. From 2005 to 2006, they worked as a Lab Technical Support in the laboratory of PT Bintang Duta, where they conducted analyses for various samples. In 2006, they joined PT Pharos Indonesia as a Regulatory Affairs Supervisor, where they handled tasks such as patent assessment, clinical data studies assessment, and dossier checking. megasari then moved to MAHAKAM Group in 2014 as an R&D-Regulatory Affairs Assistant Manager, responsible for managing the regulatory team and overseeing registrations and variations for drugs, medical devices, cosmetics, and household products. In 2016, Megasari joined COMBIPHAR as a Regulatory International Market Manager, a role they held until 2018. megasari was later promoted to Senior Regulatory International Market Manager, and in January 2021, they became the Head of Regulatory Affairs for the Combiphar Group. Throughout their career, Megasari has demonstrated expertise in handling regulatory affairs for international markets and has executed pre-market approvals, product registrations, pharmacovigilance activities, advertising, and licensing for importers and distributors.

Megasari Utami completed their Bachelor's degree in Chemistry from Undip, where they studied from 1998 to 2003. megasari has also obtained the Lean Six Sigma Fundamentals certification from LinkedIn in October 2016.

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