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Regulatory Affairs Associate Publishing

Company

Parexel

Location

Remote, Remote

Type

Full-time

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...

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