The Staff IT Compliance Analyst plays a critical role in ensuring that the Manufacturing IT group operates in full compliance with regulatory requirements, industry standards, and Regeneron's internal quality procedures. This role also oversees the preparation and management of internal and external audits to maintain a state of inspection readiness.
As a Staff IT Compliance Analyst, a typical day might include the following:
* Providing expert guidance and analysis to the Manufacturing IT team on regulatory compliance, quality assurance, and inspection readiness, while managing internal programs to ensure audit preparedness.
* Evaluating, developing, and refining Manufacturing IT policies, standard operating procedures (SOPs), and practices to align with regulatory requirements, corporate quality standards, and industry best practices.
* Representing and supporting Manufacturing IT subject matter experts (SMEs) during internal and external audits, while leading the development and execution of responses to audit findings.
* Establishing, maintaining, and improving metrics to monitor IT compliance, inspection readiness, and audit outcomes, and effectively communicating these findings to stakeholders.
* Collaborating with global sites to ensure deployed systems comply with business needs, regulatory expectations, and data integrity requirements, while promoting a culture of quality and continuous improvement.
* Monitoring industry trends in audit observations and regulatory changes, identifying potential compliance gaps, and implementing timely corrective or preventive actions.
* Supporting IT quality processes, including managing IT deviations, change controls, and the creation or revision of IT quality documents, while demonstrating flexibility and cross-functional expertise.
This role may be for you if you have:
* A deep understanding of GxP regulations (e.g., FDA 21 CFR Part 11, EU Annex 11) and expertise in IT system validation and qualification processes.
* Proven ability to apply quality assurance principles to IT compliance activities, ensuring systems and processes meet both regulatory and corporate quality standards.
* Strong analytical and problem-solving skills, with a proactive approach to identifying and resolving compliance risks.
* Excellent communication and collaboration skills to work effectively across global teams and interact with regulatory inspectors or auditors.
In order to be considered for this position, you must hold a BS/BA in Information Technology or related field required along with
* Principal IT Compliance Analyst: 8 years of relevant experience.
* Staff IT Compliance Analyst: 10 years of relevant experience.
* May consider equivalent combination of education and experience. Level is determined based on qualifications relevant to the role.
* Quality Assurance (QA) experience strongly desired.
* Experience in the pharmaceutical or biotechnology industry preferred.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels For additional information about Regeneron benefits in the US, please visit For other countries' specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location.
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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.