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At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager, GCP Auditing to join our Global Development Quality Assurance (GDQA) team, supporting clinical development activities across our global portfolio. You will build strategic partnerships leading risk-based quality audits across investigator sites, service providers, and internal processes, ensuring our clinical studies meet the highest standards of GCP compliance, while collaborating with study teams, cross-functional partners, and regulatory colleagues around the world.This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.Discover your role:Own the end-to-end audit process — scheduling, preparing, conducting, reporting, and following up on routine and directed auditsLead a range of audit types across sites, vendors, license partners, and internal processes globallyApply deep knowledge of FDA, EU, and ICH regulations to independently resolve a variety of GCP compliance issuesRepresent GDQA on cross-functional teams and complex compliance projects spanning multiple departmentsInterpret regulations and quality standards, evaluating critical issues that fall outside existing guidanceSupport clinical study teams by developing and implementing risk-based audit strategiesStep into regulatory inspections as part of the control or inspection room team when neededMentor and help onboard new GDQA staff, sharing your auditing expertiseThis role requires:Bachelor's degree with 6+ years of relevant industry experience including 4+ years of direct GCP audit experience. Background supporting risk-based audit strategy development for clinical studiesExperience applying FDA and EU regulations including ICH E6 R3 and applicable standards.Ability to effectively manage multiple complex priorities and make complex decisions with a sense of urgencyStrong track record of project management, stakeholder management, collaboration skills and negotiation of complex situationsRegeneron 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/.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 to work and educational qualifications.
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