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.
...About the RoleWe are seeking a dynamic, results-driven Marketing Specialist to join our team. As a key member of National Marketing Team for... ...across all marketing channels, including digital, social media, email, content marketing, events, and traditional advertising.-...
...life science product and service solutions around the globe. Repair Technician I - Savannah, GA When surgical instruments are... ...small hand tools is a plus. Examples are small engine repair, cell phone and electronics repair, testing, or re-builds, carpentry, circuit...
Duties: Job Profile Summary: Responsible for the engineering of network infrastructures including hardware, software, and various configurations. Ensures that the design and integration of proposed solutions leads to the development and growth of the business through ...
...Benefits: Competitive salary ($310,000 - $390,000 annually, based on experience) Hybrid work model with flexibility for remote work Enhanced mentor program for lateral associates Comprehensive pro bono program offering credit for community legal work...
...Sylvan Learning Center - High School English Tutor 9th - 12th (Part-Time) Are you a highly skilled and motivated individual who loves teaching and inspiring students? Do you have a passion for English and want to make a positive impact on students' academic success? If...