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.
...Full-Time Salary :$85,000 - $120,000 (compensation iscommensuratewith experience) Location :Hybrid Clearance Requirement: Public Trustsecurity clearance eligibility required Position Overview :The Business Analyst supports PMO implementation and...
...Groundfloor, a hyper-growth wealthtech company based in Atlanta, is seeking a Digital Graphic Designer who specializes in creating high-performing, conversion-optimized marketing assets at scale. You'll be the creative engine behind our digital marketing campaigns, producing...
...us at razorfish.com. Overview We're looking for a Junior Visual Designer who's eager to grow, ready to contribute, and excited... ...experiences is a MUST A four-year degree (preferably in graphic design) or related experience Familiarity with...
...need to complete a background check Candidates will need to complete a drug test. Candidates must obtain and maintain security clearance. Application Instructions Send your resume to ****@*****.***. We will then email you our employment application...
Were hiring a Maintenance Technician at JVM Realty! Join our team and help keep our community safe, functional, and welcoming for residents... ...orders, repairs, and preventative maintenance Troubleshoot HVAC, plumbing, electrical, and appliance issues Assist with...