Senior Manager, Clinical Study Inspection Readiness

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.

• Location:
  
  Armonk, NY, Warren, NJ
• Travel percentage:
  Up to 25%

• 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

• 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

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…