Senior Regulatory Affairs Associate Publishing

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 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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