N022 - Regulatory Affairs And Quality Technical

As Regulatory Affairs and Quality Technical, you will support all related activities for Corify's products, including but not limited to:Collecting and summarizing regulatory intelligence.Performing regulatory assessments.Participating in project teams.Providing input for regulatory submissions.Managing the compilation and review of all submissions for completeness and quality.What we need:Manage regulatory projects and closely collaborate with Clinical and Regulatory Operations.Provide tactical support for the timely preparation, editing, and review of submissions, including regulatory agency Meeting Requests and Briefing Documents, IND/CTA amendments, original BLAs, and international Marketing Authorization Applications and their respective amendments/supplements.Coordinate and manage regulatory submission documents (e.G., cover letters, Meeting Requests, Meeting Briefing Packages, etc.) to produce submission-ready content.Manage the quality, accuracy, compliance with internal and external standards, and the timely production of submission documents using manual and electronic document management systems.Assist with logging, tracking, and filing of correspondence with regulatory authorities and ensuring that no commitment remains unduly outstanding.#J-18808-Ljbffr