Regulatory Affairs Consultant - E2E Labelling

<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>We are seeking an experienced <b>Regulatory Affairs Consultant</b> specializing in global labelling operations to join our growing Regulatory Affairs team. This role offers the opportunity to shape labelling strategy across multiple markets and drive global alignment of product information for pharmaceutical portfolio of our clients.</p><p></p><p><u>The role can be fully home based or office based.</u></p><h2></h2><h2>Key Responsibilities:</h2><ul><li><p>Manage <b>end-to-end labeling lifecycle</b> including preliminary assessment, implementation, and post-approval maintenance</p></li><li><p>Provide innovation and technical expertise for the creation, maintenance, and implementation of labeling to meet country-specific regulatory requirements</p></li><li><p>Execute labeling operations globally with precision and efficiency</p></li><li><p>Participate in a &#39;follow the sun&#39; model to ensure timely execution of labelling activities across time zones</p></li><li><p>Prepare and review labelling documents for regulatory submissions and variations</p></li><li><p>Maintain labeling databases and tracking systems</p></li><li><p>Support global labelling harmonization initiatives</p></li><li><p>Collaborate with regional regulatory teams to ensure compliance with local requirements</p></li><li><p>Monitor regulatory intelligence related to labelling requirements</p></li></ul><p></p><p><b>Skills and Experienced required for the role:</b></p><ul><li><p>University degree in a life science discipline</p></li><li><p>A few years of experience in the biotech/pharmaceutical industry</p></li><li><p>Labelling/regulatory experience with global responsibilities</p></li><li><p>Experience with CCDS development and maintenance</p></li><li><p>Strong understanding of regulatory labelling requirements across multiple markets</p></li><li><p><b>Direct experience working with BfArM</b></p></li><li><p>Excellent attention to detail and organizational skills</p></li><li><p>Experience leading teams in a matrix organization is expected</p></li><li><p>Ability to work effectively in a global, virtual team environment</p></li><li><p><b>Fluent in German and English, written and spoken</b></p></li></ul>