Job Description
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
Education:
- Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field (or equivalent work experience).