Vipin Jaiswal

Executive Drug Regulatory Affair @Brawn Laboratories Limited

Faridabad, IN

Being an Executive Drug Regulatory Affairs My role involves handling regulatory affairs and ensuring compliance with country - specific Guidelines!At my current position, I am responsible for collecting technical documents from Plants and various departments and conducting thorough cross-checks to ensure adherence to the checklist requirements. I excel at preparing and compiling Country-Specific Dossiers, CTDs, and ACTD formats for the Global Markets. Additionally, I am skilled in providing prompt query responses to clients and MOH within the timelines defined by the Regulatory Authorities by coordinating with internal departments to meet regulatory requirements;Maintaining an updated database is crucial in my work, and I ensure that it reflects most recent quality document updates. I am also responsible for updating the registration dossier document sheets for both submitted products and those that have obtained approval or registration certificates. Before proceeding with compilation, I review and discuss any document gaps to ensure the Accuracy and Completeness.Furthermore, Document tracking and the management of regulatory samples are areas where I contribute my expertise and support. I take a proactive approach to follow-up with respective departments to arrange necessary documents promptly!Throughout my career, I have developed strong attention to the detail, the excellent organizational skills, & a deep understanding of regulatory processes. I thrive in dynamic & fast-paced environments, leveraging my communication skills to effectively collaborate with the cross-functional Teams.I am enthusiastic about contributing my knowledge and expertise to pharmaceutical industry and furthering the success of my organization!