Senior Regulatory Affairs Consultant – EU Regulatory Strategy, MAA

🔥 0 minutes ago

🌐 Romania, Croatia, +3 more countries – Remote

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

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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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

• Lead and manage Marketing Authorisation Applications (MAAs) with strategic regulatory input on application pathways and dossier packages • Develop and execute regulatory strategies aligned with product development timelines and commercial objectives • Conduct critical document reviews and provide competitive regulatory intelligence to support informed decision-making • Prepare core regulatory documents including briefing books, paediatric development plans, and scientific advice packages • Own Module 1 submission documentation and coordinate submission preparation activities • Manage responses to health authority questions and requests with timely, high-quality deliverables • Ensure timely execution of regulatory activities across assigned products and programmes • Lead pre-submission activities, scientific advice procedures, and post-approval regulatory maintenance with the European Medicines Agency (EMA) • Serve as key interface with health authorities and cross-functional stakeholders including Clinical, Medical, Safety, Quality, CMC, and Commercial functions • Influence senior stakeholders and navigate complex regulatory challenges in a consultancy environment

🎯 Requirements

• University degree in a Life Science discipline • Significant Regulatory Affairs experience supporting EU product development and lifecycle management • Proven experience leading or supporting EMA interactions and regulatory procedures • Strong understanding of Marketing Authorisation Applications (MAAs) and CTD/eCTD dossier requirements • Experience preparing and reviewing regulatory documentation, including Module 1 content and health authority briefing materials • Demonstrated expertise in regulatory strategy development, dossier review, and health authority engagement • Excellent project leadership, stakeholder management, and communication skills • Ability to manage multiple regulatory priorities while delivering high-quality outcomes in a fast-paced environment • Fluent in English, written and spoken