Senior Regulatory Affairs Associate – Regional Submission Coordinator

🔥 8 minutes ago

🌐 Hungary, Romania, +3 more countries – Remote

🇭🇺 Hungary – Remote 🇷🇴 Romania – Remote 🇵🇱 Poland – Remote 🇱🇹 Lithuania – Remote 🇷🇸 Serbia – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

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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

• Coordinate the preparation, compilation, and submission of new drug applications and lifecycle management activities across assigned regions • Coordinate with Global Submission Coordinators to ensure completeness of core documentation for regional submission planning • Organize submission team meetings and facilitate communication among CMC, labelling, regulatory leads, local regulatory representatives, and regulatory partner representatives • Open records in submission planning tools and Regulatory Information Management Systems • Prepare Submission Content Plans based on country-specific regulatory requirements and prior Health Authority observations • Request and track documentation from subject matter experts to ensure timely and complete submission readiness • Provide submission status and timeline updates to the submission team • Draft M1 documents and coordinate their review • Support labeling preparation in artwork management and change control systems • Upload M1 documents to the archiving system and complete Submission Content Plans • Dispatch and track non-eCTD regulatory packages to local and partner regulatory representatives • Upload submitted documentation to the archiving system for non-eCTD submissions • Update Veeva with Health Authority questions and other required information

🎯 Requirements

• University degree in Life Sciences discipline • 3–5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry • Experience with regulatory submission strategy and execution, ideally global • Strong understanding of regional regulatory submission processes • Experience with different international regulatory submission routes preferred, such as ACCESS and reliance pathways • Excellent project management and organizational skills • Strong communication and stakeholder management abilities • Proficiency in regulatory tracking systems, including Veeva, and Microsoft Office Suite • Fluent in English, written and spoken