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.

- Robust 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.

📌 Manager Site Start UP EUCTR (Hyderabad)
🏢 Regeneron
📍 Hyderabad