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.
Business Development Representative (BDR) Location Stockton, CA : Sales Representatives initiate and manage relationships with customers and serve as the point of contact for the Company. This position is responsible for coordinating selling efforts to grow new and incremental...
...Villages, FL is seeking its next amazing RN (Registered Nurse) to work in Home Health. Read on if this sounds like your perfect fit! Nurses and... ...demand nationwide, and our team of industry-leading, traveler-favorite recruiters can get you where you want to go personally...
...healthy work environment and provides appropriate safety training for all personnel as required. The position includes domestic travel to meet with partners and stakeholders. Paid holidays after 6 months of employment. Benefits after 90 days. NSDI values inclusion...
...Job Overview Are you an experienced Registered Physical Therapist looking for an exciting new opportunity? As a key member of our patient care team, you will play a crucial role in helping our patients recover from injuries and improve their physical function. With...
...boutique hospitality group setting the standard for DC dining through ambitious restaurant concepts. We are currently seeking a Digital Marketing Manager to lead our digital presence, content strategy, and brand storytelling. The ideal candidate has a deep love of restaurants...