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

<p><b>When our values align, there's no limit to what we can achieve.</b><br/> <br/>At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.</p><p>Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.</p><p></p><p></p><p>We are seeking a highly organized and strategic <b>Senior Regulatory Affairs Associate specializing in Artworks</b> to join our team. In this pivotal role, you will work with various clients, develop and execute artwork strategies for our global product portfolio, ensuring comprehensive oversight throughout the product lifecycle.</p><p></p><p><u>The role can be home or office based in various European locations.</u></p><p></p><p><b>Role Responsibilities:</b></p><p>Strategic Leadership</p><ul><li><p>Execute and maintain artwork implementation strategies across our global portfolio</p></li><li><p>Serve as the main point of contact for Regulatory Affairs on all artwork matters</p></li><li><p>Proactively address planning requirements and CAPA (CC, Deviation, Complaint) issues</p></li><li><p>Develop and maintain global product portfolio plans, including change assessments</p></li><li><p>Establish strong connections with key stakeholders (Regulatory Affairs, Supply Chain, Technical Operations)</p></li><li><p>Represent the Artwork team to Regulatory Affairs and other departments as needed</p></li></ul><p>Change Proposal Management</p><ul><li><p>Track project management for artwork-related initiatives</p></li><li><p>Process change proposals, including reception and documentation</p></li><li><p>Plan and coordinate project kick-off meetings</p></li><li><p>Monitor timelines, follow up on approvals, and track implementation</p></li><li><p>Document first released batches with new artworks</p></li><li><p>Ensure clear communication across multiple stakeholders</p></li></ul><p>Artwork Project Management</p><ul><li><p>Create and schedule artwork projects</p></li><li><p>Coordinate artwork creation and approval processes</p></li><li><p>Track all project tasks to meet cross-functionally agreed timelines</p></li><li><p>Collaborate closely with internal and external stakeholders</p></li><li><p>Create and manage Mock-Up projects in artwork management systems</p></li><li><p>Ensure timely completion of tasks aligned with deliverable expectations</p></li></ul><p></p><p><b>Skills and Experience required for the role:</b></p><ul><li><p>Bachelor's Degree in a Scientific or Technical Discipline</p></li><li><p>3-5 years of experience in an industry-related environment</p></li><li><p>In-depth understanding of pharmaceutical industry regulations, particularly in Regulatory and Supply Chain</p></li><li><p>Comprehensive knowledge of end-to-end Labeling &amp; Artwork activities</p></li><li><p>Strong project management capabilities</p></li><li><p>Client-focused approach with results orientation</p></li><li><p>Excellent teamwork and collaboration abilities</p></li><li><p>Critical thinking and problem-solving aptitude</p></li><li><p>Fluent in English written and spoken</p></li></ul><p></p><p></p>