Associate Director Inspection Management (GCP)
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Job Summary
Build our future together:
At Regeneron we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director Global Inspection Management Lead to join our Global Development Quality function supporting our clinical development organisation in a hybrid work this role you will lead global inspection management across clinical programmes while collaborating with Clinical Study Teams quality functions and process owners. This position offers the opportunity to contribute to a fast-growing science-driven organization making a meaningful difference to patients worldwide.
When & where:
Multiple locations are being considered for this role (Hybrid).
Discover your role:
Manage notifications for anticipated and confirmed regulatory inspections.
Integrate inspection processes and training into clinical development programmes.
Guide Clinical Study Teams through inspection preparation and risk mitigation.
Coordinate mock inspections and site preparation visits with Global Development Quality Assurance.
Lead front-room or back-room activities during worldwide GCP GVP and GLP inspections.
Coordinate inspection requests responses updates and executive summaries.
Manage response development Corrective and Preventive Actions follow-up and quality metrics.
You build trusted partnerships while guiding teams through complex inspection challenges.
This role requires:
Bachelors degree and at least 10 years relevant healthcare or pharmaceutical industry experience.
Advanced Good Clinical Practice or Good Pharmacovigilance Practice knowledge.
Quality compliance Quality Assurance or Clinical Development experience with transferable GCP or GVP expertise.
Extensive GxP inspection experience across investigator sites sponsors and Clinical Research Organizations.
Experience preparing facilitating and following up regulatory inspections and complex compliance issues.
Experience training supervising mentoring developing staff and leading a small team.
Strong stakeholder management collaboration presentation and relationship-building skills.
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 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 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)
101500.00 - 165200.00Required Experience:
Director
About Company
Discover how Regeneron (NASDAQ: REGN) harmonizes biology and technology to create life-changing medicines. Join our team and explore clinical trials.
