Executive / Sr. Executive - Global Regulatory Labelling

Job Description

Compilation and/or initial review of labeling documents for OSD Injectable for original ANDA and Additional strength submission. Co-ordinate with CFT for involvement and understanding of priorities and filing timelines. Follow-up with respective department to get documents in timely manner and to ensure that all labeling modules are available for submission on time. To be updated with current labeling practices and regulatory guidelines. Initial review of all deficiency query responses related to US Labeling for both OSD and Injectable. To ensure that all labeling modules are available for CR, IR and DRL submission on time. Co-ordination with cross-functional teams as needed to collect required documents for deficiency responses. To compile deficiency responses. To achieve 100% launch readiness for all new products, with zero labeling issues. To ensure most recent and updated labeling has been issued Ok-To-Print. To ensure all printed labeling will be available for launch and on time. To ensure Drug listing of First Launch products after approval. To ensure labeling docs are available on time for successful execution of Site Transfer projects. To ensure labeling docs are available on time for successful execution of Additional Site Transfer activities. Introduction of labeling for Third party. Assist in review of all RLD updates of OSD Injectable. To ensure that all labeling modules are available of RLD update for submission within time. To co-ordinate with supervisor for involvement and understanding of priorities. Initiation/Facilitate Change Control and LRC for all labeling changes. To approve Softcopy (vendor copy), transparency, shade card, First Print. To create Barcode Grade report. To address all annual reportable changes for labeling. To compile labeling templates for Annual Report, PADER, and APQR. Must have knowledge for Safety labeling change Notification. Good hold on Patent and Exclusivity for labeling carve out. Able to work on labeling SOPs.