Regulatory Affairs Consultant - CMC biologics (home or office based)

<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>Are you an experienced regulatory affairs professional looking for a new opportunity? We are currently seeking a talented <b>Regulatory Affairs Consultant </b>to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various European locations.</p><p></p><p>As the Regulatory Affairs Consultant you will play a vital role in our company&#39;s worldwide post-approval regulatory activities, specifically focused on Chemistry, Manufacturing, and Controls (CMC) for biological products.</p><p></p><p><b>Primary Tasks &amp; Responsibilities:</b></p><ul><li><p>Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports.</p></li><li><p>Assess change controls and provide regulatory assessments of quality changes in production and quality control.</p></li><li><p>Review study reports from the quality control and production departments to ensure compliance with regulatory requirements.</p></li><li><p>Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies.</p></li><li><p>Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.</p></li><li><p>Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions.</p></li><li><p>Identify, escalate, and mitigate risks associated with regulatory procedures and activities.</p></li></ul><p></p><p><b>Experience and Knowledge Requirements:</b></p><ul><li><p>University-level education, preferably in Life Sciences, or equivalent by experience.</p></li><li><p>Previous experience in regulatory affairs, particularly related to <span>technical/CMC/quality,</span> within the pharmaceutical industry.</p></li><li><p>Strong understanding of CMC and post-approval regulatory requirements.</p></li><li><p>Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations.</p></li><li><p><u>Knowledge of biological processes.</u></p></li><li><p>Background in validation/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation. Understanding of <span>qualification/validation</span> principles.</p></li><li><p>Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued.</p></li><li><p>Team spirit, flexibility, accountability, and organizational skills.</p></li><li><p>Fluent in English (written and spoken).</p></li></ul><p></p>