Senior Regulatory Affairs Associate - France Local Regulatory Responsible Person

<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<span> </span><b>Senior Regulatory Affairs Associate</b><b><span> </span>to serve as the France Local Regulatory Responsible (LRR)</b>, focusing on local regulatory requirements and Health Authority national engagements. In this client-facing role, you will have an<span> opportunity to work in a complex global matrix organization, serving as a subject matter expert and making meaningful contributions to regulatory strategy and compliance. You will collaborate with diverse teams across regions and play a crucial role in ensuring regulatory excellence for French markets.</span> <u>The role can be home or office based.</u></p><p></p><p><b>Key Responsibilities</b></p><p>Strategic Execution &amp; Compliance Management</p><ul><li><p>Provide local inputs to develop and execute innovative regulatory strategies for new product registrations and lifecycle management activities</p></li><li><p>Ensure strict compliance with local regulations and actively participate in policy activities with industry groups and trade associations</p></li><li><p>Act as RA representative in audits/inspections, ensuring readiness and timely CAPA closure</p></li><li><p>Monitor regulatory landscape changes and communicate requirements to Global Regulatory Affairs (GRA) and local teams</p></li></ul><p>Health Authority Engagement &amp; Submissions</p><ul><li><p>Serve as primary interface with <span>ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé)</span>, industry groups, and trade associations</p></li><li><p>Lead in-country regulatory processes for licenses, partner regulatory licenses, and market access collaborations</p></li><li><p>Prepare and coordinate local-specific documentation (e.g., Module 1) to meet national submission requirements</p></li><li><p>Monitor status of submitted regulatory activities and ensure timely completion</p></li></ul><p>Lifecycle Management &amp; Compliance</p><ul><li><p>Manage comprehensive lifecycle activities including variations, renewals, PSURs, and PIP submissions</p></li><li><p>Ensure timely submission of renewals and mandated post-approval applications</p></li><li><p>Maintain RIMS database with current local activity and track compliance KPIs</p></li><li><p>Oversee compliant labelling (RCP, Notice, packaging) including updates, translations, and promotional material review</p></li></ul><p>Cross-Functional Collaboration</p><ul><li><p>Act as primary RA representative for local Commercial Operations (ComOps)</p></li><li><p>Support regional regulatory TA teams within GRA for efficient planning and submission preparation</p></li><li><p>Collaborate with Global Labelling for Foundational Labelling Processes</p></li></ul><p></p><p></p><p><b>Experience &amp; Expertise</b></p><ul><li><p>University degree in a life science discipline</p></li><li><p><u>Minimum 5 years&#39; experience in French Regulatory Affairs, with strong understanding of French and EU regulatory requirements</u></p></li><li><p>Proven experience with multiple submission types: CP, MRP, DCP, and National procedures</p></li><li><p>Comprehensive lifecycle management expertise for French submissions</p></li><li><p>Experience with ANSM submission processes and requirements</p></li><li><p>Competence in labelling management (updates, mock-up review, and print release processes)</p></li><li><p><span>Medical device knowledge advantageous, but not essential</span></p></li><li><p>Familiarity with systems such as Veeva Vault</p></li><li><p>Excellent organizational, time management, and interpersonal skills in a global environment</p></li><li><p>Proven ability to work effectively both independently and in teams</p></li><li><p>Strong project management and leadership capabilities</p></li><li><p>Expertise in influencing stakeholders and driving business-critical decisions</p></li><li><p><u>Fluent in French and English (oral and written)</u></p></li></ul><p></p><p></p>