Apoorva Mirche

About Apoorva Mirche

I am currently working as a Executive FR & D Non Oral (complex injectables) at Sun…

Experience

1. Executive

   SUN PHARMA

   Jul 2024 — Present · Vadodara, IN

   With my extensive experience in Formulation R&D, I have developed a strong foundation in injectable product development, regulatory compliance, and technical documentation, which will be highly valuable in a Regulatory Affairs role. My expertise in formulation design, excipient selection, QbD-based development, and process optimization has given me a deep understanding of the scientific and regulatory aspects of pharmaceutical products. Additionally, my involvement in compiling and analyzing critical data, preparing technical documents (MFRs, BMRs, PDRs, and scale-up reports), and ensuring regulatory compliance throughout the product development lifecycle aligns closely with the responsibilities of a Regulatory Associate.Furthermore, my experience with technology transfer, exhibit batch manufacturing, and plant execution has provided me with insights into regulatory expectations during scale-up and commercialization. My ability to collaborate with cross-functional teams, interpret regulatory guidelines, and ensure seamless documentation will enable me to effectively support regulatory submissions, dossier preparation, and compliance activities. With this background, I am confident that my transition to Regulatory Affairs will allow me to bridge the gap between product development and regulatory requirements, ensuring smooth approvals and market entry for pharmaceutical products.