Stalin Sam

Background

About Stalin Sam

Publishing and Product License Support (PPLS) Responsible for publishing, validating and QC of various electronic formats such as NeeS, eCTD and Paper Submissions assuring the quality and completeness of the submissions. Assist Regulatory Associate Trainees for document level publishing which includes bookmarking, hypertext linking and preparing Tables of Contents as per the guidelines. Regularly update and maintain regulatory submissions database & maintain archives. Support to regulatory submission publishing such as US-FDA, EU and Health Canada. Expertise in US - Adpromo and RISC submission. Basic knowledge in Safety submissions,submission publish activities. Perform QC for regulatory submissions. Contribute essential and viable knowledge to teams on regulatory operation technical points to assure timely and systematically managing of eCTD/CTD submissions.