Manager Site Start UP EUCTR

Build our future together  At Regeneron, Global Clinical Trial Operations transforms clinical development plans into well-executed studies that can bring important medicines to patients. As Manager, Site Start-Up, EU Clinical Trials Regulation, you will lead the planning and delivery of Part II clinical trial applications through the Clinical Trials Information System. You will connect Regulatory Affairs, Clinical Trial Management, Clinical Transparency, contract research organizations, and study sites to establish submission strategies, manage country and site documentation, respond to authority questions, and protect critical start-up timelines. Your work will strengthen regulatory compliance, improve submission quality, and help studies progress efficiently across European Union Member States.   When & where Location: Hyderabad  Discover your role  • Lead the planning and execution of European Union Clinical Trials Regulation Part II submissions throughout the study lifecycle.  • Partner with Clinical Trial Management and Regulatory Affairs to define country allocation, submission strategy, breakthroughs, and timelines.  • Coordinate Member State, institution, principal investigator, and site-level information and documentation required for clinical trial applications.  • Prepare and maintain accurate submission content in the Clinical Trials Information System and ensure alignment with national requirements.  • Collaborate with Clinical Transparency on document redactions and collect compliant documentation for In Vitro Diagnostic Regulation ethics submissions.  • Triage Requests for Information and coordinate timely, complete responses with relevant cross-functional stakeholders.  • Supervise submission progress, country and site milestones, risks, and dependencies, escalating issues that could affect study-start timelines.  • Be responsible for internally handled and outsourced studies, maintain inspection-ready records, and develop control documents, job aids, and process improvements.  This role requires  • A bachelor’s degree and at least 7 years of relevant clinical research experience; an advanced degree may be considered in place of some experience.  • Hands-on experience in clinical drug development and study start-up, including European Union Clinical Trials Regulation Part II submissions.  • Solid understanding of ICH Good Clinical Practice, the European Union Clinical Trials Regulation, and In Vitro Diagnostic Regulation requirements.  • Strong project-management skills with the ability to plan breakthroughs, handle risks, prioritize deadlines, and solve problems using data.  • Effective communication, influence, and negotiation skills across cross-functional study teams, vendors, contract research organizations, and sites.  • Experience using clinical trial management and trial master file systems, with strong proficiency in Microsoft Project, PowerPoint, Word, and Excel.  • Direct experience preparing and maintaining Part II applications in the Clinical Trials Information System.  • Experience handling Requests for Information, country-specific documents, redactions, and submission breakthroughs across multiple Member States.  • Proven vendor oversight and experience balancing internally handled and outsourced studies.  • Experience developing control documents, job aids, and continuous-improvement solutions for site start-up processes.  Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all  qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual ori