Within this role you will be reporting to the Assoc Director Payroll the Assoc Manager will be responsible for assisting our Payroll manager and the team with all day to day processes involved in running the end to end payroll process. This is a 18-month temporary contract. A typical day might include, but is not limited to, the following: Conducting payroll audits and reviews prior to Associate Director Approval Working with accounting to ensure all payroll data required for month end is provided in a timely and accurate manner Preparing and/or reviews and inputs all administrative payroll data changes to records for processing of our bi- weekly and monthly payroll Working with other departments such as Comp & Bens and HRPB's to ensure payroll data is correct and processed accordingly Reconciling each payroll, reviews all entries and forwards for approval Ensuring all tax information, reconciliations and payments Managing the internal inbox with responsibility for responding to employees' queries Assisting with audit queries related to payroll Performing other duties or projects as assigned by management This role may be for you: You thrive in a fast-paced, deadline-driven environment and can juggle multiple priorities You communicate clearly and effectively with internal teams and external partners You are comfortable working hands-on while providing strategic oversight You have strong analytical skills and a keen eye for detail To be considered this opportunity you should a bachelor's degree in accounting, finance, or business as well as 6 years of expereince. Advanced Excel skills (including pivot tables, formulas, and lookups), experience with Workday, Oracle or Core is strongly preferred have a payroll experience, including having worked as a payroll manager with direct people management responsibilities. 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. 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.
We are seeking a Sr Automation Engineer who will be responsible for the administration, configuration, implementation, maintenance and ongoing support of various manufacturing equipment specific applications and Systems in a cGMP environment. As a Sr Automation Engineer (Small Manufacturing Equipment), a typical day might include the following: Providing end-user support for small manufacturing equipment applications including troubleshooting issues and appropriately communicating items to management, business process owners and users Type of equipment range from standalone equipment such as UV Specs, pH meters, particle samplers to networked equipment such as wave rockers, LabX instruments and cell analysers Overseeing and executing of automation preventative maintenance activities Being responsible for generating automation documentation such as SOPs, work instructions and configuration specification documents Performing daily business administrative tasks related to functional support and general user account administration Providing SME support and working closely with functional departments on projects to develop, implement and enhance systems Implementing software/hardware changes and upgrades, understanding impact of actions to manufacturing and facilities Providing assistance prior to, during and post regulatory/partner inspections Supporting automation change control requests Participating or leading small manufacturing equipment projects to introduce new equipment or upgrade existing applications To be considered for this position you should have a Bachelor's degree in Computer Science, Chemical, Mechanical, or Electrical Engineering and the following minimum years of relevant experience for each level: Engineer: 2+ years Senior Engineer: 5+ years Principal Engineer: 8+ years Level will be determined based on qualifications relevant to the role. #REGNIRLTO 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. 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.
The Senior Manager of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the assigned Therapeutic Area. We will expect this to include safety data aggregation, review and analysis to support appropriate safety interpretation and benefit-risk assessment. In this role, a typical day might include: Complete signal detection activities in line with approved safety surveillance plan Perform signal evaluation for any identified signals and author the safety evaluation reports Manage preparation and review of safety documents including DSUR, PSUR, RMP, response to health authority or other queries Prepare and deliver presentations at Signal Management Team (SMT) meetings; participate in clinical study team meetings for assigned compounds Participate in other risk management activities as appropriate for assigned compounds We may ask you to represent GPS on cross-functional teams, including Regeneron Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC) and other teams with members external to Regeneron Actively participate in process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents This role might be for you if can/have the: Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments Ability to work with a safety system database for purposes of medical case review and simple queries Able to be proactive and self-disciplined, you can meet deliverables, and effectively use your time and prioritize Ability to effectively communicate (verbal and written) safety findings To be considered for this opportunity, you must have the following: Minimum a Master's, PhD, or PharmD Offers 7+ years of relevant risk management experience in the pharmaceutical/ biotech industry or health authority 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. 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. Salary Range (annually) $150,500.00 - $245,500.00
The Global Patient Safety (GPS) Lead role (Director of GPS) serves as the first point of contact (POC) for all safety related issues for the compound(s) [asset(s)] assigned within a given therapeutic area (TA), and is the GPS representative on the cross functional strategic program team (SPT) for the compound. The GPS Lead leads the safety strategy and ensures the optimal support from within GPS and works collaboratively with stakeholders to deliver the safety strategy. This position requires the ability to work with and influence colleagues in a matrix environment within and external to GPS including senior management. The GPS Director joins Regeneron's industry leading scientific organization, and has a direct impact on drug development, operations, and commercialization in all relevant global territories. In this role, a typical day might include: This Director position is directly responsible for all aspects of Global Patient Safety activities for assigned compounds and products in support of safety surveillance, signal management, communication of the safety profile as appropriate for the stage in the asset lifecycle, benefit risk assessment, safety responses to regulatory agency queries, safety documents (DSURs, PSURs, development RMPs, RMPs, etc.) and the review of clinical documents (Investigator Brochures, protocols, clinical study reports, etc.) Leads cross-functional Safety Monitoring Team (SMT) activities Represent Global Patient Safety for assigned compounds on cross-functional teams, including Regeneron's Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC), Strategic Program Team (SPT) and other teams with members external to Regeneron (alliance partners, CROs) Proactively identify and develop safety strategies and planning for non-compound specific Global Patient Safety activities (mechanism of action etc.) Act as a resource for medical review for complex ICSRs, and other data sources of assigned compounds Actively participate in the development and maintenance of relevant SOPs, working practices and guides Actively participates in continuous improvement activities within both the TA and the GPS organization, including cultivating cross functional relationships and mentoring junior safety scientists This role might be for you if can/have: Ability to apply and provide critical analysis of relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required. Function as a subject matter expert internal and external to GPS for assigned compounds with relevant clinical industry experience in the therapeutic area of interest. A proven ability to lead and develop a diverse team of Safety Professionals in a constructive, goal-oriented environment. An ability to work across organizational levels, effectively communicating safety viewpoints and findings as required, and recommended risk management and minimization activities. Ability to utilize GPS safety database for purposes of medical case review and simple queries. To be considered for this opportunity, you must have the following: Minimum 10+ years of total relevant experience in PV and/or relevant medical field or equivalent of industry experience in drug safety including significant experience with PSURs/ DSURs/(d) RMPS; or in clinical development with demonstrated achievements in safety (ex. supporting an ISS; responsible for CSR content). 5+ years of total relevant experience in PV and/or relevant medical field with PharmD / PhD / MD degree required. Clinical experience and/or industry experience in Oncology is a plus #MDJOBSPS 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. 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. Salary Range (annually) $205,000.00 - $341,600.00
The Director Program Operations Leader (POL) is responsible for leadership and overall strategic management of one or more complex programs in Clinical Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The Dir POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. Director, Program Operations Leader - Internal Medicines For Uxbridge and Dublin, colleagues must be on-site 3 days per week and 2 days from home. A fully remote role is not possible for this position. The Dir POL is responsible for line management of clinical trial management staff, including responsibility for staff recruitment, development, coaching, mentoring, and performance management. In a typical day, you will: Be responsible for the overall success of the clinical study team(s) within a program(s) Maintain an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level updates to stakeholders as requested Provide operational insight into feasibility, timeline and cost estimates during clinical program/study development Oversee clinical study timelines within a clinical program(s) Provide input and operational insight into Clinical Study Concepts (CSC) Review of plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies. Ensure consistency within the program and development of best practices within CTM Oversee clinical study budgets within a program: ensures review, presentation and approval of initial study budget and manages the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriate Ensure timely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s). Drives decision making and integrates all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation Be responsible for direct supervision of CTM staff. Line management responsibilities include: work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight. To be considered, you must possess: A Bachelor's degree and minimum of 12 years relevant in-house sponsor-side industry experience, 8 years within clinical operations. For US Locations, this position is on-site 4 days per week and 1 day from home. 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. 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.
We are seeking an Automation Infrastructure Engineer who will be responsible for delivering and maintaining automation-based systems and solutions which provide for flexible, innovative, cost effective, compliant and quality-focused manufacturing of Biopharmaceuticals. As an Automation Infrastructure Engineer, a typical day might include the following: Supporting critical-to-manufacturing systems and ensuring their high availability reducing or eliminating unplanned downtime Designing, configuring, programming, and qualifying Rockwell FactoryTalk Systems (DCS), ThinManager; Asset Centre Excellent understanding of protocols such as OPC, UPC-UA, MQTT, TCP/IP, HTTP Ensuring appropriate monitoring, alerting and response to network, system and application issues affecting functionality and availability Providing automation technical knowledge and support for troubleshooting, investigations, installations and training Providing automation system design for data integrity, stability, and integration between different systems Designing and delivering end-to-end data solutions to meet current and future needs Facilitating the smooth transition of projects from Development into Production Environment Overseeing migration of data from legacy systems to new applications Acting as a Subject Matter Expert and the technical go-to for Historian and data integration solutions Ensuring compliance and optimisation of automation systems Creating, modifying, and maintaining automation systems and documentation, including automation specification documents and SOPs, in a compliant state Working closely with the corporate IT infrastructure team to ensure continued technical alignment. Managing support for manufacturing dependencies and touchpoints with enterprise systems Supporting the validation of automation systems with QA Validation Designing and implementing solutions across automation platforms in line with the site change control procedures Implementing and reporting of preventative maintenance, patching & upgrades Developing a plan for system obsolescence, vendor support and upgrade scheduling This role might be for you if you: Have some experience with cGMP and validation pertaining to biopharmaceutical production operations and computerised systems and the ability to implement best practices (GAMP) to ensure site automation systems are cGMP compliant Have an understanding of automation system implementation and validation life cycle along with an understanding of the product quality impact of changes Demonstrated capability for leading complex projects technically from initial design / development through to the validation of the facility in support of defined objectives Experience of implementing change controls and investigating system deviations/events Experience with SQL databases Experience with networking: Cisco, Stratix Switches, Firewalls Experience with Enterprise Security: Antivirus and network security Experience with monitoring and security tools such as Splunk Want to challenge the status-quo and champion an environment where continuous improvement is not just metrics - it's a mentality for everyone, every day, to do better To be considered for this position you should have a Bachelor's degree in Computer Science, Chemical, Mechanical, or Electrical Engineering and the following minimum years of relevant experience for each level: Engineer: 2+ years Senior Engineer: 5+ years Principal Engineer: 8+ years Level will be determined based on qualifications relevant to the role. #REGNIRLTO 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. 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.
As a Manager Global Procurement you will take a lead in the development and implementation of the our Global Clinical Category Management strategy by gathering and anticipating business supply needs and specifications. We aim to manage a supply base and enhance value, minimize risk, and ensure quality & cost effectiveness by working collaboratively with business unit. A typical day may include the following: Collaborating with partners leading discussions related to the Global Clinical Category strategies and aligns category priorities. Manages negotiations, supplier management activities, and partner engagement activities. Drives value in terms of cost savings, cash flow improvement, and other efficiency savings. Represents Global Procurement by participating in organizational decisions in Global strategies with critical short and long-term impact on the success, efficiency, growth, and results. Demonstrates knowledge of efficient global procurement organizations and processes within the biopharmaceutical industry to support the growth and evolution of the organization and leverages this knowledge to drive improvements aligning with corporate priorities. Manages category activities to ensure compliance with any & all appropriate GxPs and other applicable regulations Negotiates contract terms and conditions in consultation with Law department aligned with Regeneron's priorities and business requirements. May, either directly or through a matrix structure, manage team of professional level employees responsible for performing category management tasks (if applicable.) Uses data to drive decision-making for successful category projects. Coaches proficiency on procurement technical skills among global procurement team. This role may be for you if you ... Can build relationships with collaborators and suppliers to drive results for Regeneron. Use external data sources, market information, and supplier engagement to continuously improve your knowledge of supply market dynamics. Operate with integrity, focus, and clarity in an environment of ambiguity to lead change and improvement. Want to have an impact on patient lives To be considered you are to have a bachelor's degree in a relevant field of study plus 6+ years of relevant, progressive experience in procurement, including experience in Pharma/BioPharma. Experience successfully managing clinical category processes, and suppliers across a breadth of categories is required. Your experience will include demonstrated success working effectively with cross-functional teams through effective sourcing, negotiations, contracting, and supplier relationship management. 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. 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. Salary Range (annually) $113,100.00 - $184,700.00
The Senior Manager, Global Development Quality Management (GCP) acting as a Quality Management Lead (QML) is a key position that will provide guidance and leadership for all aspects of quality and compliance within Global Development Quality (GDQ) systems. The GDQM (GCP) QML will engage with key stakeholders, build strategic partnerships working and liaising with study teams, relevant functions and other GDQ functions to lead risk-based quality management activities on all Regeneron-sponsored clinical trials, inclusive of issue management and providing continuous support of inspection readiness. For US locations (Armonk, NY or Warren, NJ), this role is on-site 4 days in the office and 1 day from home. For Uxbridge, UK or Dublin, Ireland this role would be on-site 3 days per week and 2 days from home. A fully remote role is not possible for this position. A day in the life may look like: Acting as a Subject Matter Expert (SME) and key liaison to GDQ to provide support and advise on any quality issues to ensure compliance and for the Quality Risk Assessment process. Ensuring and responsible for Risk-Based Quality Management (RBQM) initiatives and process improvements, in partnership with other functional areas. Responsible for the management of GCP-compliant activities from a quality perspective in conjunction with the business and the GDQM (GCP) team. Providing day-to-day quality and compliance support to cross-functional stakeholders, including issue management (triage/investigation/actions), audit responses, proactive quality management, Corrective Action/Preventive Action (CAPA) oversight, audit/issue trending. Engaging with, supporting, and liaising with multiple cross-functional stakeholders whose work impacts the GDQ system. Leading Quality Risk Assessment and Control Tracker (QRACT) activities at the time of Protocol development predicated on ICHGCP. This may be the right role for you if you have experience: Bachelor's degree with a minimum of 8 years of relevant healthcare/pharmaceutical industry experience. Experience working in either a quality/compliance role (e.g., Quality Management, Quality Assurance etc.), or in a Clinical Development role with expertise and/or transferable skills related to Good Clinical Practice (GCP), and/or Good Pharmacovigilance Practice (GVP). Providing consultation, mentorship, training, and support in respect to compliance with applicable international regulations, practices, and guidelines. Advising on the escalation of any quality issues that potentially represent serious non-compliances (or serious breach) via the issue escalation process. Supporting the collection and reporting of data (e.g., metrics). Contributing to and supporting process improvement initiatives and workgroups, as assigned. Exemplifying a quality mindset and behaviors in all interactions with internal and external colleagues, serving as an ambassador for GDQ. In order to be considered for this role, we are looking for candidates who have: 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. 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. Salary Range (annually) $134,400.00 - $219,200.00
The Senior Manager, IT Applications - QC and Process Sciences is accountable for the stability, compliance, and performance of enterprise applications with a primary focus on QC & Process Sciences lab systems. You will lead the run operations for LabWare/LIMS, Empower, NuGenesis, and SoftMax, ensuring validated, secure, and efficient support for IOPS quality operations. This role partners closely with QC, QA, Validation, Manufacturing, and Global IT to deliver reliable sample lifecycle management, data integrity, and audit-ready computerized systems under cGMP/GxP. As a Senior Manager IT Applications - Run, a typical day might include the following: Lead the end-to-end run function for the QC informatics stack (LabWare/LIMS, Empower, NuGenesis, SoftMax), including integrations with instruments, ERP/MES, and data repositories. Own service delivery for QC applications across incident, problem, change, release, and configuration management, aligning with ITIL and GMP change control. Maintain validated state for QC systems: risk assessments, validation plans/reports, periodic reviews, audit trail assessments, access management, backup/restore, disaster recovery, and cybersecurity controls. Drive data integrity (ALCOA+) by enforcing role-based access, segregation of duties, electronic signatures, audit trail review processes, and safeguarding raw and derived data. Partner with QC leadership and System Owners to map and optimize sample and method workflows, specifications, stability studies, and lot-release processes within LIMS/CDS/SDMS. Establish and monitor operational metrics and dashboards (SLA adherence, right-first-time rates, change success rate, validation cycle time, audit observation closure, system availability). Coordinate vendor and partner management (system integrators, instrument vendors) and oversee upgrades, patches, and technology refreshes with minimal GMP impact. Prepare for and support internal/external audits (e.g., FDA/EMA, client audits), drive CAPA effectiveness, and ensure sustained inspection readiness. Author and maintain SOPs, user guides, and training materials; deliver role-based training to QC end-users and administrators. Collaborate globally with Application Leads to ensure alignment, share best practices, and standardize configurations and procedures across sites. Communicate status, risks, and resource needs to executive stakeholders; prioritize investments based on QC operational impact and compliance risk. Champion continuous improvement using MDI structures, lean practices, and automation to reduce manual steps and error risk in QC workflows. Manage budget, capacity planning, and on-call coverage to support 24x7 QC operations during campaigns, investigations, and release activities. This Role May Be For You If You Enjoy: Reviewing overnight QC system performance, audit trail exceptions, and critical incidents; triaging and assigning tasks. Meeting with QC, QA, and Validation to prioritize change controls and minor enhancements aligned to release timelines. Approving Empower project configurations or LIMS workflow updates and ensuring proper documentation and validation impact assessment. Conducting user access reviews, periodic system health checks, and data integrity spot audits. Coordinating a vendor-supported patch or instrument driver update, executing installation in a controlled, validated manner. Updating executive stakeholders on KPIs, risks, and mitigation plans; adjusting resources to meet key priorities. In order to be considered for this position, you must hold a BS/BA in Information Technology or related field and 8+ years of relevant experience or equivalent combination of education and experience. 5+ of those years must include managing systems and people. Preferred Experience: Demonstrated experience leading QC laboratory informatics in a cGMP/GxP environment, including run operations for LIMS, CDS, SDMS/ELN/LES. Strong knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, CSV practices, data integrity principles (ALCOA+), and audit readiness. Hands-on administration experience with: LabWare LIMS (configuration, workflow design, user roles, reporting). Empower CDS (project administration, privileges, audit trail, e-sig, backup/restore). NuGenesis SDMS (archival, search, report management, retention). SoftMax Pro (method management, data export, integration considerations). Experience integrating lab instruments (e.g., chromatographs, balances, plate readers) via vendor toolkits/drivers; familiarity with Windows Server, Active Directory, and database technologies (e.g., SQL). Proven track record implementing ITIL processes within GMP change control, managing releases with minimal operational disruption. 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. 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.
The Senior Manager of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the assigned Therapeutic Area. We will expect this to include safety data aggregation, review and analysis to support appropriate safety interpretation and benefit-risk assessment. In this role, a typical day might include: Complete signal detection activities in line with approved safety surveillance plan Perform signal evaluation for any identified signals and author the safety evaluation reports Manage preparation and review of safety documents including DSUR, PSUR, RMP, response to health authority or other queries Prepare and deliver presentations at Signal Management Team (SMT) meetings; participate in clinical study team meetings for assigned compounds Participate in other risk management activities as appropriate for assigned compounds We may ask you to represent GPS on cross-functional teams, including Regeneron Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC) and other teams with members external to Regeneron Actively participate in process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents This role might be for you if can/have the: Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments Ability to work with a safety system database for purposes of medical case review and simple queries Able to be proactive and self-disciplined, you can meet deliverables, and effectively use your time and prioritize Ability to effectively communicate (verbal and written) safety findings To be considered for this opportunity, you must have the following: Minimum a Master's, PhD, or PharmD Offers 7+ years of relevant risk management experience in the pharmaceutical/ biotech industry or health authority #GDPSJobs 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. 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. Salary Range (annually) $150,500.00 - $245,500.00
