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.
• Must Have knowledge for threshold analysis (labeling part only).
• 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.
• Must have good English communication skill.

B. Pharm/M. Pharm