San Francisco Bay Area
I am a motivated life science graduate working on drug development as a Manager in Regulatory Affairs. Experienced in US and EU regulations governing clinical study conduct, preparing dossiers for NDA/BLA submissions, providing regulatory support for clinical trials and labeling needs. I hope to apply my knowledge towards getting important treatment options to patients as safely and effectively as possible.
My responsibilities include leading sub-teams for sBLA dossier preparation, managing timelines and stakeholders for various projects including periodic report submissions, IND maintenance activities, participating in Clinical Study Management Teams and Regulatory Affairs Functional Teams to provide regulatory intelligence and input.
As a part of my PhD I have worked on multiple projects involving development of neurons and their function as well as transplantation strategies for neurodegenerative diseases. I have extensive experience in reading and writing scientific literature in the form of grant applications and research articles. I have been a part of several collaborative projects and have acquired the interpersonal skills needed to help move things along smoothly. I have found this to be an essential skill contributing to a good and productive work environment.
As a visiting graduate student at UCSD, I continued working on my PhD projects and many more collaborative projects.
My responsibilities included experimental design and execution. My primary focus was studying motor function and bilateral processing following brain injury in animal models.