Associate Director Inspection Management (GCP)

The Associate Director, Global Development Quality Inspection Management (GDQIM) acting as an Inspection Management Lead (IML) plays a key role in managing GCP, GVP and GLP inspections across Regeneron-sponsored clinical trials. The GDQIM IML engages with stakeholders, builds strategic partnerships, and supports Clinical Study teams, relevant functions and other GDQ functions to ensure effective inspection preparation.

Typical Day Activities

• Ensuring and managing the notification of all relevant internal and external stakeholders of upcoming and/or anticipated regulatory inspections.
• Ensuring the preparation, management and integration of inspection management processes and training activities into clinical development programs and all relevant stakeholders.
• Providing effective guidance, consultancy, and support to Clinical Study Teams and key stakeholders in advance of an impending inspection.
• Assisting with the identification of opportunities to conduct mock inspections and/or Investigator Site Preparation Visits, in collaboration with the GD Quality Assurance (GDQA) team and other relevant functional groups.
• Identifying and discussing potential issues and gaps that may require strategies to mitigate risk and provide additional clarification to an inspector.
• Ensuring the preparation, management and conduct of inspection preparation sessions, including mock inspections, training, and clinical site preparation visits, working with GDQA to identify and mitigate risks to clinical programs.
• Serving as the back room lead/co lead or front room co lead, managing all activities, tracking of requests and inquiries, and coordinating responses during any regulatory inspection worldwide.
• Managing preparation and provision of timely inspection updates and daily/end of inspection summaries to GD Executive and Senior Management.
• Managing inspection response development and CAPA follow up activities alongside GDQIM colleagues, cross functional stakeholders, and process owners.
• Ensuring and managing development, collection, reporting and analysis of inspection related quality data, trends, and metrics.

Essential Qualifications

• Advanced knowledge and application of GCP, and/or GVP guidelines, including management of significant/complex quality issues and compliance activities.
• Extensive experience participating in, and supporting, regulatory agency inspections of investigator sites, sponsors and CROs in a GxP environment, including inspection preparation, facilitation and follow up.
• Effective management of interpersonal relationships, stakeholder engagement and collaborations.
• Demonstrated ability to interface and collaborate effectively with other managers and directors within and external to the organization.
• Extensive experience providing training and presenting information on key quality and regulatory compliance information.

Desired Experience and Education

• Bachelor's degree and a minimum of 10 years of relevant healthcare/pharmaceutical industry experience.
• Experience working in a quality/compliance role (e.g., Quality Management, Quality Assurance) or in a Clinical Development role with GCP and/or GVP expertise or transferable skills.
• Experience in training, supervising, line management, mentoring and development of staff, and leading a small team.

Salary Range (annually): €101,500.00 - €165,200.00

Regeneron offers a competitive and comprehensive total rewards package that may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (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

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.