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...