高级法规事务顾问 – 欧盟法规策略与上市许可申请

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. We are seeking an experienced Regulatory Affairs Professional to provide strategic leadership and execution support across the full lifecycle of medicinal product development and registration within Europe. This role is ideally suited to a regulatory professional who combines deep EU regulatory expertise with strategic thinking, strong client-facing skills, and the ability to lead complex regulatory programmes from development through post-approval lifecycle management. In this role, you will lead and manage Marketing Authorisation Applications (MAAs), providing strategic regulatory input on both the overall application pathway and the full dossier package. You will play a key role in the development and execution of regulatory strategies, conduct critical document reviews, and provide competitive regulatory intelligence to support informed decision-making and successful regulatory outcomes. The successful candidate will actively contribute to regional and global regulatory activities, including leading the preparation of core regulatory documents such as briefing books, paediatric development plans, scientific advice packages, and other key regulatory deliverables. You will support investigational, new, and marketed product submissions while serving as a key interface with health authorities and cross-functional stakeholders. The role can be home or office based in Poland, Croatia, Hungary, Romania or Serbia. Key Responsibilities 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 Skills and 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 Originally posted on Himalayas