mahima dubey

I am a detail-oriented regulatory affairs professional with a Master's Degree in Biochemistry with 2 years and 6 months experience of Regulatory affairs in Pharmaceutical Industry. My background includes expertise in drafting / reviewing CMC sections of eCTD /CTD, regulatory submission, cross- functional collaboration and serving as a direct connect to other country partners. 

I have navigated regulatory requirements for various markets, including India, Indo-ASEAN, Health Canada, EMA and other developed market dependent Health agencies.

I excel in fast paced environments, managing new product submission, life cycle management for a drug product ensuring regulatory compliance and addressing deficiency queries. My passion regards my career is to ensure high quality products reaching the market successfully and efficiently while meeting all regulatory standards. I thrive on collaboration and strategic problem solving to drive successful outcomes.

• I have a Master's Degree in Biochemistry.
• To deepen my expertise in Regulatory Affairs, I completed the Global Regulatory Affairs program offered by Biocon Academy in collaboration with JSS Medical AHER College.