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.
...Sustainability team. This internship will focus on supporting our work with LEED (Leadership in Energy and Environmental Design) and... ...sustainability standards. This is a valuable opportunity for a student or early-career professional to gain hands-on experience in renewable...
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...
...visiting , or our parent company at Position Overview We are seeking asummer intern. Thedesired areaof interest is Mine Engineering. The intern season will begin between mid-May/early June 2025 and run through August 2025. The location is in Monroe,MI....
...depending on volume received for the day Mailroom Clerical Lockbox Mail Clerk duties: Cut and sort incoming mail from the Post Office. Process Lockbox accounts by extracting the contents, negotiate the checks and prepare the output according to the customer...
...Job Description: At USENV, our Class A/B Truck Drivers transport hazardous and non-hazardous waste. Team members are responsible for... ...conducted in a safe and compliant manner. You would operate a roll-off truck, or a Class A Truck with a roll-off trailer. Trucks have...