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.
H&K Group, Inc. seeks an experienced Primary Plant Operator to manage the operation of our material handling machinery at one of our key facilities. This role is pivotal in ensuring efficient production processes and maintaining the highest standards of safety and quality...
Amergis Staffing is currently seeking Part Time/Full Time School Aides for the 25/26 school year to assist students in the classroom setting within... ...safety and well-being of the children. Requirements:+ High school diploma+ Previous experience working with young children...
...seeking hard working, motivated individuals for an entry level mining position and is assigned to the underground mining operations.... ...policies, federal and state laws, and regulatory standards Experience Prior experience in oil and gas industry, manufacturing, construction...
Great opportunity for fellowship trained vascular surgeon to build practice 1 hour to Pittsburgh. Call coverage is available from General Surgery. Ideal situation with an underutilized specialized equipment, labs, and dialysis clinic. Can be 100% Vascular/Endovascular,...
...Position Summary : Creating and developing new product designs and patterns for HIMACS and VIATERA as well as the Surfaces Division... ...Experience: Undergraduate degree in textile, graphic, interior, industrial design or related field. Less than 2 years experience (...