Senior Regulatory Affairs Consultant
22 ore fa
When our values align, there's no limit to what we can achieve.We are seeking an experienced Regulatory Affairs professional to join our team as a European Labelling & Promotional Regulatory Specialist. This key position provides expert guidance across a Therapeutic business unit, delivering both strategic and operational regulatory input to cross-functional teams.The role can be home or office based in various European locations.Key ResponsibilitiesEU Product Information Management :Create, update and maintain EU Product Information in line with CCDS, Agency RTQ, and current labelling requirementsServe as the key point of contact for EU Product Information for both internal and external stakeholdersLead reviews, round tables, and approvals for EU Product Information in appropriate systems according to SOPsDeliver competitive labelling searches and contribute to TCLP for early development assetsOperational Excellence :Ensure timely tracking and management of all EU Product Information in appropriate systemsLead Readability Testing processes including vendor selection, agreement management, questionnaire review, and submission of final reportsCoordinate Linguistic Review processes with LR Coordinator according to SOPsCommunicate proactively with SPA for artwork and mock-up changes, participating in Change Control ProcessesLeadership & Collaboration :Lead the Local Labelling Committee for creation, review and approval of EU Product InformationServe on the EU Clearance Committee as primary regulatory reviewer for promotional materialsBuild strong relationships with EU and Global Regulatory teams, local business partners, SPA, and PLG teamsMonitor changes in EMA labelling requirements and keep the organization informed of technology requirementsQualifications & Skills required for the role :University degree in a life science disciplineStrong knowledge of EU regulatory requirements for product labelling and promotional materialsExperience with electronic content management systems and regulatory SOPsExcellent project management and organizational abilitiesOutstanding written and verbal communication skillsProven ability to work effectively in cross-functional teamsFluent in English, written and spoken#J-18808-Ljbffr
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