Thejesh Gowda

Background

About Thejesh Gowda

Labeling, AR and PADER 1. Handling both post-approval and pre-approval labeling activities such as RLD Update and Labeling Deficiency Management. Drug listing of the drug product NDC and to ensure labeling compliance. Uploading and formalization of documents in eCTD format using eCTD dossier management software. Review and approval of artworks through OAMS required for compilation of regulatory submissions and deficiencies responses. Preparation, Review and Compilation of documents for PADER and Annual Reports CMC & Compliance 1. Handling of Post Approval Supplement Activities including supplement triggered form vendor change management. Preparation, review, and compilation of regulatory documents for post approval supplements being filed for US market. Regulatory authorization/approval activities in SFG, FG, protocols and review of master documents (Specifications [RM and FP], MFR and MPR), risk assessment reports [EIRA, NIRA and RSL]. Tracking & maintenance of various regulatory database that fosters regulatory compliance.