Senior Manager, Clinical Study Inspection Readiness Employer Regeneron Pharmaceuticals, Inc. Location Armonk, New York Start date Aug 20, 2026 View more categories View less categories Discipline Clinical , Clinical Research Required Education Bachelors Degree Position Type Full time Hotbed Pharm Country , Best Places to Work Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job Job Details Company Job Details Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, Clinical Study Inspection Readiness to join our Clinical Trial Management function, supporting inspection readiness across one or more assigned clinical programs. In this role, you will lead GCP inspection readiness strategy and serve as the primary point of contact for all inspection-related activities, while collaborating closely with Program Operations Leaders, Clinical Study Leads, CRO partners, and Inspection Management. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. When & where:

Location:

Armonk, NY, Warren, NJ Travel percentage: Up to 25% Discover your role: Lead GCP inspection readiness programs across complex, multi-program portfolios spanning internal teams, CRO partners, and Inspection Management Own the inspection process end-to-end mock, dry run, and actual managing follow-up requests from inspectors and inspection management teams Partner with Clinical Study Teams and functional areas to prepare Q&A responses and drive action items to closure Guide CTM staff on compliance with SOPs, Business Practice Tools, and Work Instructions throughout the study lifecycle Track inspection readiness meetings, action items, storyboards, and presentation requests with internal and CRO stakeholders through resolution Manage the full inspection action item lifecycle from pre-inspection readiness through post-inspection remediation, timelines, and closure ensuring a complete audit trail Champion use of AI-powered tools to accelerate high-quality deliverables, from executive summaries and storyboards to CAPA narratives and TMF gap analyses Coach, develop, and set goals and accountabilities for direct reports, reviewing performance against quality and timeliness standards This role requires: BS/BA degree and 8+ years of relevant clinical experience Strong project management instincts, especially under the pressure of live inspection timelines

Preferred:

hands-on clinical inspection experience (mock, dry run, or actual regulatory inspections)

Preferred:

experience partnering with CROs and cross-functional clinical study teams

Preferred:

familiarity with AI-powered productivity tools (e.g., Claude, Microsoft Copilot) in a documentation or compliance context Proactive risk thinking identifying Sites of Interest and documentation gaps before they become findings Clear, confident communication across internal teams, CRO partners, and inspectors Comfort leading and coaching others while staying hands-on with the details 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 onsite. Please speak with your recruiter and hiring manager for more information about onsite 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. Salary Range (annually) $150,500.00 - $245,500.00 Company Regeneron is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.

Stock Symbol:

REGN Stock Exchange:

NASDAQ Company info Website https://www.regeneron.com/ Phone 914-847-7000 Location Corporate Headquarters 777 Old Saw Mill River Road Tarrytown New York 10591 United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert Similar jobs Executive Director, Global Medical Affairs, GU, GI & Hematology Platform Thousand Oaks, California Clinical Engagement Lead - West / Midwest United States Senior Director, Project Management South San Francisco, CA