Regulatory Affairs Associate

🕒 July 6

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• 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. • Familiarity with end‑to‑end submission lifecycle maintenance processes (preferred). • In-depth knowledge of FDA and international regulatory agency requirements (preferred). • Prior experience with document control or compliance‑driven workflows (preferred). • Strong background in document preparation and formatting (preferred).

🏖️ Benefits

• Competitive salary • Professional development opportunities