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.
Long term contract position in a shipyard in Mobile, AL Weld pipes using various techniques such as TIG Cuni and Stainless Skills: 5 years' experience in pipe welding techniques including TIG welding on CUNI and Stainless Pipe in a shipyard. Must be able to ...
A Senior Graphic Designer involves leading design projects from concept to completion, overseeing and mentoring junior designers, and ensuring brand consistency across all visual assets. Key responsibilities include creating high-level visual concepts for digital and print...
...Responsibilities, not limited to. Ensure that your menus are clean at all times Ensure the guest feels welcome by greeting them within two... ...in keeping the venue clean and safe at all times Follow all cash handling policies and procedures Maintain a positive,...
.../dramatic play, cooking, circle and story time, fine and gross motor skill building, and... ...benefit of 24 hours per year. There is no cash value associated with the benefit.No other... ...offered. This position is at will and is not part of the City's Civil Service System. There...
...new role, we are looking for YOU! Dont miss this opportunity to join a rapidly growing and well-regarded organization. The Case Manager will report to the Clinical Supervisor. In collaboration with other members of the clinical team, the case manager is responsible...