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.
...organized Content Manager to help tell our story, build engagement, and grow our customer base. Job Overview: We are seeking a Graphic Designer to create engaging content to further establish each brand by creating engaging content including graphics, videos, decks and...
...West Odessa off I-20 Join the premier oilfield services company in Midland/Odessa-- Rolfson Oil LLC. Put your expertise to work onboardingnew hires for fuel, oils and lubricants, rentals, propane, mechanics, tanks, and facilities positions. Separate departments for...
JOB DESCRIPTION Job Title Healthcare Technical Consultant - North Florida Job Description Allow your passion for improving lives... ...must be able to: Work in an office/home office and/or remote setting, as well as in a hospital/healthcare environment;...
Making a difference in the world by reducing carbon emissions and improving access to clean energy with every module we make. Our purpose is to make a difference in the world by reducing carbon emissions and improving access to clean energy with every module...
...of Richland, Washington is seeking a full-time, permanent Dental Hygienist to join their team! The Dental Hygienist Job Details... ...benefit package ~ Responsible for providing dental hygiene care for dental patients. Functions of dental hygiene, in addition...