Senior Regulatory Affairs Consultant - Labelling (home or office based)

This a Full Remote job, the offer is available from: Hungary, Poland, Romania, Spain, United Kingdom, Ireland, Czechia, Italy, Croatia, Serbia, reputed company (USA) reputed company our values reputed company, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From reputed company to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. reputed company of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. About the Role We are seeking an reputed company Regulatory Affairs reputed company to join reputed company 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 Responsibilities EU Product Information Management: • Create, update and maintain EU Product Information in line with CCDS, Agency RTQ, and reputed company labelling requirements • Serve as the key reputed company of contact for EU Product Information for both reputed company stakeholders • reputed company reviews, round tables, and approvals for EU Product Information in appropriate systems according to SOPs • Deliver competitive labelling searches and contribute to TCLP for early development assets Operational reputed company: • Ensure reputed company tracking and management of reputed company EU Product Information in appropriate systems • reputed company Readability Testing processes including vendor selection, agreement management, questionnaire review, and submission of final reports • Coordinate Linguistic Review processes with LR Coordinator according to SOPs • Communicate proactively with SPA for artwork and mock-up changes, participating in Change Control Processes Leadership & Collaboration: • reputed company the Local Labelling Committee for creation, review and approval of EU Product Information • Serve on the EU Clearance Committee as primary regulatory reviewer for promotional materials • Build strong relationships with EU and Global Regulatory teams, local business partners, SPA, and PLG teams • Monitor changes in EMA labelling requirements and reputed company the organization informed of technology requirements Qualifications & Skills required for the role: • University degree in a life science discipline • Strong knowledge of EU regulatory requirements for product labelling and promotional materials • Experience with electronic content management systems and regulatory SOPs • Excellent project management and organizational abilities • Outstanding written and verbal communication skills • Proven ability to work effectively in cross-functional teams • Fluent in English, written and spoken This offer from "reputed company" has been enriched by reputed company.com and got a 0% reputed company score. Apply tot his job Apply To this Job