Regulatory Affairs Associate

<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><b>Regulatory Affairs Associate </b></p><p></p><p>2 to 4 years of experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts.</p><p>• To understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.</p><p>• Support authoring Annual reports/Renewal experience US/ <span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">EU/Brazil/LATAM/China.</span></p><p>• Liaise closely with cross-functional members with aligned product responsibilities.</p><p>• Knowledge of change evaluation according to country guidelines</p><p>• Experience in managing lifecycle activities in the EU markets would be preferrable</p><p>• Knowledge of CTD guidelines</p><p></p>