Senior Regulatory Affairs Associate – Regional Submission Coordinator

🕒 July 7

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

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 (LCM) activities in alignment with submission strategy • Coordinate closely with Global Submission Coordinators to ensure completeness of core documentation required to support regional submission planning and requirements • Organize submission team meetings and facilitate effective communication among all stakeholders • Open required records in submission planning tools and Regulatory Information Management Systems • Prepare Submission Content Plans (SCP) based on country-specific regulatory requirements • Coordinate, request, and track documentation from relevant SMEs to ensure timely and complete submission readiness • Provide regular updates to the submission team on status and timelines • Draft M1 documents as required and coordinate their review with LRR or RPR • Support labeling preparation, notably in Artwork management system and change control system • Upload M1 documents in archiving system and complete the SCP accordingly • Ensure dispatch of non-eCTD regulatory packages to LRR and RPR • Track dispatched documentation for each country • Ensure submitted documentation is uploaded to archiving system for non-eCTD submissions • Update Veeva as required.

🎯 Requirements

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

🏖️ Benefits

• Health insurance • Professional development opportunities