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 orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.