Senior Regulatory CMC Project lead

<p><strong>About the Job</strong></p><p>At Excelya, where <strong>Audacity, Care, and Energy</strong> are at the core of everything we do, we are seeking a <strong>Senior CMC Regulatory Consultant</strong> specializing in small molecules lifecycle management to join our dynamic team.</p><p>This role involves providing expert regulatory input throughout the lifecycle of small molecule products, from development to post-marketing activities. As a Senior Consultant, you will work closely with cross-functional teams to ensure robust regulatory strategies, compliance, and submission excellence.</p><p>The main objectives of this role are to lead the CMC Regulatory strategy of a small molecule asset (late phase; MAA under preparation) within a truly global scope and to&nbsp;manage and deliver the CMC Dossier with the support of the technical writing team within the Regulatory CMC.</p><p><strong>Main Responsibilities:</strong></p><ul><li>Leading the global CMC Regulatory strategy for one small molecule asset (late phase; MAA under preparation)</li><li>Defining, developing, owning and executing the global CMC Regulatory strategy whilst maximizing the regulatory outcomes for this asset.</li><li>Ensure that CMC Regulatory strategies are an enabler to potential accelerated product development pathways to ensure speed up product delivery to patients.</li><li>Effective project management skills to ensure high quality and timely delivery of regulatory documents.</li><li>Leading the CMC strategy for all agency interactions for the allocated asset (including the preparation of the BB).</li><li>Represent CMC Regulatory on the asset cross-functional technical, regulatory and governance meetings as needed.</li><li>Provide CMC Regulatory support to the Reg CMC technical writing team in relation to the respective country requirements</li><li>Liaise with the Local Affiliate of the respective countries to develop efficient regulatory strategies to deliver the CMC Dossier in line with country requirements and agreed timelines</li><li>Generate gap analysis and risk management support for each submission in the core markets as needed</li><li>Compile regulatory documents in support of each submission in the core markets on time and in line with country requirements</li></ul><p><strong>Requirements</strong></p><ul><li>Degree in pharmacy, chemistry, pharmaceutical sciences, or related field.</li></ul><ul><li>Extensive experience in CMC regulatory affairs focused on small molecule lifecycle management, preferably within pharmaceutical industry or consultancy.</li></ul><ul><li>Strong knowledge of global regulatory frameworks (EMA, FDA, ICH) and lifecycle management principles.</li><li>Proven ability to lead CMC regulatory projects and collaborate with multidisciplinary teams.</li><li>Excellent communication, analytical, and organizational skills</li><li>Fluency in English; French language skills are a plus.</li></ul><p><strong>Benefits</strong></p><p><strong>Why Join Us?</strong></p><p>At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.</p><p>Here’s what makes us unique—&nbsp;</p><p>We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s&nbsp;<strong>leading mid-size CRO&nbsp;</strong>with the&nbsp;<strong>best employee experience</strong>. Our&nbsp;<strong>one-stop provider service model</strong>—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey.</p><p><strong>Excelling with care</strong>&nbsp;means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.</p><p>Find more <a href="https://www.arbeitnow.fr/english-speaking-jobs">English Speaking Jobs in France</a> on Arbeitnow</a>