Industry - Pharmaceuticals

Skills - Labelling, R&D, Regulatory Affairs, label copy, annotation,

Job Type - Permanent

Description :

- Focus will be on all Global labeling details (labels, cartons, package inserts, patient package inserts) required to ensure quality and accurate compliance, evaluations, maintenance, reviews and approvals with cross-functional teams for regulatory submissions.

- Proofread all types of label copy/annotation/etc. at all development 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.

- Requires a BS degree in a science or related field

- Knowledge of US, EU and International regulatory requirements

- 2-5 years relevant regulatory experience (Global experience including US, EU and major Rest of World markets preferred)

Contact - Afrin Patel

The Apply Button will redirect you to website. Please apply there as well.

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.