Senior Associate, Regulatory Affairs
Recognized by Regulatory Affairs leaders for going above and beyond to help the team meet their submission deadlines. Management of the content and quality review of electronic submission of IND and NDA lifecycle management submissions, such as Annual Reports, Safety Reports, CMC Amendments. Expertise at reviewing Clinical Submissions, such as New Protocol, New Investigator and Protocol Amendment type submissions in electronic submission format. Manage multiple regulatory submission projects for multiple clients while meeting or exceeding submission deadlines. Review of eCTD backbone file structure using eCTD Viewer to make sure the documents are in the correct location and are ready to be viewed by regulatory agencies.