Regulatory Affairs Associate

Parexel

Regulatory Affairs Associate developing and publishing regulatory submissions for global health authorities at Parexel. Ensuring compliance and quality in documentation with stakeholder support.

Posted 7/6/2026full-timeRemote • 🇲🇽 MexicoJuniorMid-LevelWebsite

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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.
Familiarity with end‑to‑end submission lifecycle maintenance processes (preferred).
In-depth knowledge of FDA and international regulatory agency requirements (preferred).
Prior experience with document control or compliance‑driven workflows (preferred).
Strong background in document preparation and formatting (preferred).

Benefits

Comp & perks

Competitive salary
Professional development opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Regulatory PublishingDocument ManagementECTD StructureXML Document FormatsDocument PreparationFormattingSubmission StandardsRegulatory GuidelinesDocument ControlCompliance Workflows

Soft Skills

Attention to DetailTime Management