Regulatory Affairs Associate Publishing

**When our values align, there's no limit to what we can achieve.** At [Parexel](https://himalayas.app/companies/parexel), 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. Each of us, no matter what we do at [Parexel](https://himalayas.app/companies/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're committed to making a difference. 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. ### Required Qualifications: * 1–3 years of experience in regulatory publishing or document management within the pharmaceutical industry. * Experience working with XML or other structured document formats. * Foundational knowledge of eCTD structure and electronic submission requirements for global health authorities (FDA, EMA, Health Canada, etc.) * Proficiency with regulatory publishing systems such as Veeva, Extedo, Insight, DXC, or comparable platforms. * Solid understanding of eCTD structure, submission standards, and applicable regulatory guidelines. * Exceptional attention to detail with the ability to manage complex documentation and meet demanding timelines. ### Preferred Qualifications: * Familiarity with end‑to‑end submission lifecycle maintenance processes. * In-depth knowledge of FDA and international regulatory agency requirements. * Prior experience with document control or compliance‑driven workflows. * Strong background in document preparation and formatting. ### Skills: * Proficiency in Microsoft Word and Adobe Acrobat for document formatting, hyperlinking, and submission preparation. * Ability to work effectively in a cross-functional team environment and manage multiple tasks under tight deadlines. * The ability to quickly learn new software tools and systems. * Effective written and verbal communication skills. * Excellent English skills (oral, written and comprehensive). ### Education: * Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field (or equivalent work experience). Originally posted on [Himalayas](https://himalayas.app)