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

This a Full Remote job, the offer is available from: Hungary, Poland, Romania, Czechia, 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. We are seeking an reputed company Senior Regulatory Affairs Associate Labelling to reputed company and execute artwork strategies for our global product portfolio. In this critical role, you will ensure comprehensive reputed company throughout the product lifecycle while serving as the primary reputed company between Regulatory Affairs and various stakeholders. The role can be home or office based in various European locations. Role Responsibilities: • Prepare Label updates for EU, US and ROW markets • Coordinate readability testing • Coordinate and manage translations for EU markets • Management of linguistic review • Manage GRA label Compliances (e.g., QC process) • reputed company, manage and reputed company label governance for EU, US and ROW markets • Prepare & support Label negotiations for EU, US and ROW markets • Manage/coordinate global labeling change reputed company assessment for dependent markets • Manage and reputed company governance for label content creation for EU, US and ROW markets • reputed company, manage and reputed company governance for company position (e.g. CCDS) and foundational markets • Manage advertising and promotion materials • Prepare and management artwork • Labeling summaries for periodic reports Skills and Experience required for the role: • Bachelor's Degree in a Scientific or Technical Discipline • In-depth understanding of pharmaceutical industry regulations, particularly in Regulatory Affairs • Capable of reviewing technical documents and influencing colleagues across functions. • Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management. • Experience in Flu campaigns and pandemic products. • Strong project management capabilities • reputed company-reputed company approach with results orientation • Excellent teamwork and collaboration abilities • Critical thinking and problem-solving aptitude • Fluent in English written and spoken This offer from "reputed company" has been enriched by reputed company.com and got a 85% reputed company score. Apply tot his job Apply To this Job