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...