Lead EU regulatory strategy, submissions (MAA/CTA), label discussions, and securing approvals. Responsible for appropriate Europe Region regulatory input to project teams and regular interface with Global Regulatory Teams. Makes recommendations to Global Regulatory and drug development teams in order to shape the global strategy in line with regional/commercial objectives. Own the negotiations with health authorities. Supports the drug development strategy; defining options for Scientific Advice/Pediatric Investigation Plan, creating briefing packages and co-ordinating and leading agency meetings. Defines Europe region filing strategy (including CP, MRP, DCP); identifying risks and issues. Responsible for ensuring effective implementation of filing plan, publishing and archiving of documents. Responsible for ensuring effective planning, tracking, archiving of activities, especially submissions and key correspondence. Ensures effective planning and tracking of activities via internal tools. Supports co-ordination of the review of CMC, QRD, PSUR and labelling submissions and approval of product-related packaging as required to ensure regulatory compliance. Deliver regulatory milestones on your team including an assessment of risks and mitigations, emerging data, and the probability of success. Plan and construct the global dossier and core prescribing information including product maintenance, supply and compliance activities. Lead regulatory process improvements and initiatives.
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Careers Water Project Manager - Amarillo Amarillo, Texas Garver is seeking a Water/Wastewater Project Manager in Amarillo, TX or Lubbock, TX to join our established Texas Water team working on municipal water and wastewater infrastructure and treatment facility...
...Description Job Title Postdoctoral Researcher in Quantum Control and Information Science Location Los Alamos, NM, US Organization Name T-5/Applied Mathematics And Plasma Physics Minimum Salary Maximum Salary What You Will Do We are seeking qualified...
...career, not just a job, then apply below. Job Summary The Pipeline Rehabilitation Technician is responsible for inspecting and... ...pipelines, including CIPP lining and other no-dig methods. Operate and maintain equipment used in trenchless pipeline rehabilitation...