Sr Executive Regulatory Affairs Labelling Job In Domnic Lewis Private Limited In Mumbai

Job Description KEY ROLES/RESPONSIBILITIES: Global labeling details (labels, cartons, package inserts, patient package inserts) to ensure quality and accurate compliance, evaluations, maintenance, reviews and approvals with cross-functional teams for regulatory submissions Preparation of Labelling related documents eg SmPC, PIL and Labelling texts for submission in EU region Coordinating with the different stakeholders for timely labeling related submission/approval and query solving.

Proofreading all types of label copy/annotation/etc at all developmental stages as well as final label copy to ensure accuracy of labeling Creation of SPL for US Human and Vet product submissions, drug listing, annual establishment registration and annual self-identification for GDUFA Monitor and process innovator-labeling updates for existing generic products and ensure compliance with innovator updates, including side-by-side comparison with RLDs Responsible for coordination of CCDS development and updates of PCC products and coordination of local labeling updates.

Contribute to the development and/or review of all labeling aspects included in Promotional Material Create/revise SOPs and work instructions for labeling (including global harmonization of labeling SOPs) Development and maintenance of a central repository for all labeling components Software Handle: HARMONY SOFTWARE FOR REGULATORY AFFAIR LABELING Country Handle: EU, LATAM, ROW and USIf interested then please mail your CV at [HIDDEN TEXT] or call at 9820981582

Sr. Executive Regulatory Affairs- Labelling

Domnic Lewis Private Limited is looking for Bachelor Of Pharmacy (b.pharm) profile candidates.