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Senior Regulatory Affairs Associate Publishing

Parexel

- Remote (Mexico)
- 1w ago

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 general 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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📌 Senior Regulatory Affairs Associate Publishing (México)
🏢 JobsInSAS.com
📍 México