About Regeneron
Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, as well as redefining our understanding of health.
As a Senior Manager, EDC Development & UAT, you will lead Clinical Database Development and User Acceptance Testing (UAT) activities across the global clinical trial portfolio. You will be responsible for ensuring high-quality, compliant EDC system delivery from design through release and post-production, while driving standardization, innovation, and continuous improvement across EDC processes.
This position is office-based and will be on site at Regeneron’s Hyderabad office.
A typical day may include the following:
Leading and developing a team of Managers and specialists across EDC Development, UAT, and QC functions, including performance management and career development
Overseeing resource planning, workload allocation, and capacity management across a global portfolio
Driving end-to-end EDC database development, including eCRF design, database build, edit check programming, and post-production change management
Providing oversight of UAT activities including planning, execution, defect management, and release readiness assessments
Establishing UAT standards, templates, and quality benchmarks to ensure consistency across internal and CRO-delivered systems
Partnering with CROs and cross-functional team members to ensure alignment on database development strategy and quality results
Driving innovation by evaluating and implementing new EDC technologies and automation tools
Leading SOP development, process standardization, and continuous improvement initiatives across EDC Development and UAT functions
Acting as an escalation point for complex technical, operational, and stakeholder challenges
This job may be for you if you have:
Extensive experience with Medidata Rave, including database design, edit check programming, and platform administration
Strong expertise in EDC development, UAT methodologies, and quality management processes
Solid understanding of regulatory requirements including 21 CFR Part 11, ICH-GCP, and CDISC standards
Proven leadership experience leading teams and driving performance in a matrix environment
Experience handling CRO/vendor relationships and ensuring high-quality deliverables
Strong strategic thinking, problem-solving, and stakeholder management skills
Ability to influence without authority and collaborate effectively with senior leadership and cross-functional teams
Good to have Medidata Builder Certification, TrialGrid experience and Exposure to programming (e.g., C#)
To be considered for this role, you must have:
Bachelor’s degree in mathematics, science, information systems, or a related field (advanced degree preferred)
Minimum of 8+ years of experience in biotechnology, pharmaceutical, or healthcare industry
At least 4+ years of direct EDC development experience
Minimum 3+ years of people management experience
Proven experience leading UAT and QC functions for EDC systems
Experience building governance frameworks, SOPs, and driving process improvements in regulated environments
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.
