Piramal - Executive - Regulatory Affairs Labeling

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

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