Regulatory Affairs Associate
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Job Description
Regulatory Affairs Associate for Parexel developing and publishing regulatory submissions to health authorities. Collaborating with stakeholders to ensure compliance and quality in documentation.
Responsibilities:
- 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.
Requirements:
- 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.
Benefits:
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
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