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:
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1–3 years of experience in regulatory publishing or document management within the pharmaceutical industry.
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Experience working with XML or other structured document formats.
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Foundational knowledge of eCTD structure and electronic submission requirements for global health authorities (FDA, EMA, Health Canada, etc.)
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Proficiency with regulatory publishing systems such as Veeva, Extedo, Insight, DXC, or comparable platforms.
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Solid understanding of eCTD structure, submission standards, and applicable regulatory guidelines.
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Exceptional attention to detail with the ability to manage complex documentation and meet demanding timelines.
Preferred Qualifications:
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Familiarity with end‑to‑end submission lifecycle maintenance processes.
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In-depth knowledge of FDA and international regulatory agency requirements.
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Prior experience with document control or compliance‑driven workflows.
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Strong background in document preparation and formatting.
Skills:
- Proficiency in Microsoft Word and Adobe Acrobat for document formatting, hyperlinking, and submission preparation.
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Ability to work effectively in a cross-functional team environment and manage multiple tasks under tight deadlines.
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The ability to quickly learn new software tools and systems.
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Effective written and verbal communication skills.
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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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