6 May, 2022
About the job
Prepare, compile & review Regulatory/Quality documents to support submissions to various markets
Prepare deficiency responses, review labeling information, product monographs and marketing materials under supervision
Prepare post approval supplements / annual reports to support changes and/or manage the regulatory product life cycle as applicable
Seek guidance from other team members and manager as needed, and enhance Regulatory knowledge
Perform additional duties as assigned by the manager
Create and/or revise raw material and packaging specifications using client global specification systems.
Create and manage global change controls for these revisions to the raw material and packaging specifications.
Coordinate and interact with various internal departments like Procurement, Analytical, Technical Assurance and External manufacturers/sites, Suppliers and Distributors to understand the change, impact assessment, implementation strategy and required documentation governing the change
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