Regulatory Affairs Specialist Full-time 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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