About this role
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).