Senior Regulatory Affairs Associate

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    "startDate": "2026-06-18",
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    "jobDescription": "<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><div>Senior Regulatory Affairs Associate will be responsible for managing and maintaining regulatory data, supporting EMA submissions, and ensuring compliance with European regulatory requirements. The role involves hands-on experience with xEVMPD, Veeva Vault RIM, and lifecycle management activities across authorized and investigational medicinal products.</div><p></p><div><ul><li>Validate, maintain, and manage regulatory data for medicinal products in compliance with EMA guidelines.</li><li>Perform xEVMPD submissions via EMA Gateway and monitor acknowledgements using Register/AgXchange, EV Web, and Veeva Vault.</li><li>Support Product Lifecycle Management (PLM) activities, including variations, renewals, and regulatory updates for CAPs and non-CAPs.</li><li>Execute Post-Marketing Surveillance (PMS) and Product Update Information (PUI) activities, ensuring timely and accurate submissions.</li><li>Prepare and manage EMA deliverables such as eAF (electronic Application Forms) and eSMP (electronic Summary of Product Characteristics).</li><li>Handle submission and maintenance of regulatory documents including SmPC, PIL, and Health Authority communications.</li><li>Work on regulatory procedures such as xEVMPD, IDMP, CTA, MAA, and lifecycle management activities.</li><li>Utilize Veeva Vault RIM for submissions, tracking, and regulatory data management.</li><li>Ensure accurate data aggregation, mapping, and consistency across multiple regulatory systems and documents (RIMS, DMS).</li><li>Collaborate with cross-functional teams to ensure compliance and timely regulatory submissions.</li></ul></div><div><div></div><div><b>Required Skills &amp; Qualifications </b>​</div><ul><li>Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related field.</li><li>Proven experience in Regulatory Affairs with focus on EMA submissions and xEVMPD.</li><li>Hands-on experience with Veeva Vault RIM and regulatory submission tools.</li><li>Strong knowledge of EU regulatory processes (CTA, MAA, IDMP, lifecycle management).</li><li>Familiarity with regulatory systems such as RIMS and DMS.</li><li>Proficiency in Microsoft 365 tools (Excel, Teams, SharePoint).</li><li>Strong analytical skills with ability to collect, interpret, and map complex data.</li><li>High attention to detail and strong organizational skills.</li><li>Effective communication and teamwork abilities.</li></ul></div>",
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