Labeling - Regulatory Affairs Associate/Sr Associate

<p><b>When our values align, there&#39;s no limit to what we can achieve.</b><br /> <br />At Parexel, we all share the same goal - to improve the world&#39;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&#39;re committed to making a difference.</p><p></p><p></p><p>Join us as a <b>Global Labeling Operations Senior Regulatory Affairs Associate</b>, where you’ll work alongside a large, dedicated client team to drive impactful labeling operations across global markets.</p><p></p><p>In this role, you will oversee end-to-end labeling operations across multiple markets, for Foundational (US, EU, CH, DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering accurate, timely, and high-quality labeling updates.</p><p></p><p>This is a unique opportunity to work on diverse programs, including pandemic products and flu campaigns, while contributing to the governance, compliance, and strategy of global labeling.</p><p></p><p>Key Responsibilities:</p><ul><li>Manager internal global labeling and drug safety activities and coordinate bi-weekly updates</li><li>Coordinate readability testing (planning, team review, and communications)</li><li>Oversee translations for foundational markets (EU, CH, DE).</li><li>Coordinate and upload CH labels to AIPS; submit approved labels to external platforms (HA, ePIL).</li><li>Upload approved labels to internal systems (Documentum, Weblabel, intranet).</li><li>Manage linguistic reviews and dispatch CCDS, foundational labels, and multi-market manuscripts to stakeholders.</li><li>Perform data entry in Trackwise/Veeva and prepare annual labeling reports.</li><li>Review and update submission content plans; prepare change control documentation for CCDS-driven changes.</li><li>Prepare and manage Structured Product Labeling (SPL).</li><li>Support advertising and promotional and marketing material reviews, educational materials, and social media compliance.</li><li>Ensure compliance with country-specific regulatory requirements.</li><li>Act as key partner to GRA Regions, Regulatory CMC and Supply Chain.</li></ul><p></p><p>Qualifications:</p><ul><li>University degree in Life Sciences, Chemistry, Engineering, or related pharmaceutical field; advanced degree (MSc, PhD, PharmD) preferred.</li><li>Fluency in English (verbal and written); additional languages a plus.</li><li>Minimum 3 years of biotech/pharma industry experience, including 2&#43; years in labeling/regulatory operations</li><li>Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management.</li><li>Experience with flu campaigns, pandemic products, and direct-to-consumer advertising.</li><li>Familiarity with RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva), Apollo, Docubridge, Trackwise, and other regulatory systems.</li><li>Proficiency in Microsoft Office, SharePoint, Adobe Acrobat, TVT, PromoMats, GLAMS.</li></ul><p></p><p>Competencies:</p><ul><li>Deep understanding of regulatory requirements for drug development, global labeling, and post-marketing.</li><li>Strong problem-solving skills with the ability to analyze risk and recommend solutions.</li><li>Effective communicator, able to explain complex concepts and influence cross-functional colleagues.</li><li>Excellent organizational skills with attention to detail and strategic thinking.</li><li>Ability to thrive in complex, matrixed, and cross-cultural environments.</li></ul><p></p><p>Why Join Us:</p><ul><li>Work on impactful global programs that directly support patient safety and regulatory compliance.</li><li>Collaborate with a diverse, international team across multiple therapeutic areas.</li><li>Gain exposure to advanced regulatory systems and global labeling strategies.</li><li>Competitive compensation, benefits, and opportunities for career growth.</li></ul><p></p><p>If you’re passionate about global labeling operations and ready to make a difference in patient safety worldwide, we’d love to hear from you.</p><p></p>