Regulatory Affairs Associate Publishing

When our values align, there's no limit to what we can achieve. At 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, 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).

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