Associate Director Inspection Management (GCP)
Regeneron India Private Limited
Apply to this jobBuild 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 mode. In 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:
Bachelor’s 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 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 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 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)
€101,500.00 - €165,200.00Summary
Lead global GCP inspection management, coordinate inspections, mentor staff, ensure compliance.
Job title
Associate Director Inspection Management (GCP)
Experience level
10+ years
Minimum experience
10+ years exp
Industry
pharmaceutical
Location requirements
hybrid work in dublin, ireland; multiple locations considered
Salary
$102k–$165k
Visa sponsorship
H-1B sponsor history
Management role
Yes
Required skills
Preferred skills
Specializations
Structured locations inferred from the posting.
Dublin, Ireland