<p><b>When our values align, there's no limit to what we can achieve.</b><br><br>At <a href="https://himalayas.app/companies/parexel">Parexel</a>, we all share the same goal - to improve the world'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 <a href="https://himalayas.app/companies/parexel">Parexel</a>, 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're committed to making a difference.</p><p>Develop, publish, and support the publishing of regulatory submissions to global health authorities in alignment with established standards, requirements, and organizational commitments. Ensure all submissions are prepared in high-quality, compliant formats. Perform related activities as needed and provide support to both internal and external stakeholders.</p><h3>Required Qualifications:</h3><ul><li>1–3 years of experience in regulatory publishing or document management within the pharmaceutical industry.</li><li>Experience working with XML or other structured document formats.</li><li>Foundational knowledge of eCTD structure and electronic submission requirements for global health authorities (FDA, EMA, Health Canada, etc.)</li><li>Proficiency with regulatory publishing systems such as Veeva, Extedo, Insight, DXC, or comparable platforms.</li><li>Solid understanding of eCTD structure, submission standards, and applicable regulatory guidelines.</li><li>Exceptional attention to detail with the ability to manage complex documentation and meet demanding timelines.</li></ul><h3>Preferred Qualifications:</h3><ul><li>Familiarity with end‑to‑end submission lifecycle maintenance processes.</li><li>In-depth knowledge of FDA and international regulatory agency requirements.</li><li>Prior experience with document control or compliance‑driven workflows.</li><li>Strong background in document preparation and formatting.</li></ul><h3>Skills: </h3><ul><li>Proficiency in Microsoft Word and Adobe Acrobat for document formatting, hyperlinking, and submission preparation.</li><li>Ability to work effectively in a cross-functional team environment and manage multiple tasks under tight deadlines.</li><li>The ability to quickly learn new software tools and systems.</li><li>Effective written and verbal communication skills.</li><li>Excellent English skills (oral, written and comprehensive).</li></ul><h3>Education: </h3><ul><li>Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field (or equivalent work experience).</li></ul><p>Originally posted on <a href="https://himalayas.app">Himalayas</a></p>