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 integral 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 su

📌 Regulatory Affairs Associate Publishing (México)
🏢 Parexel
📍 México