Within this role you will be responsible for specifies instrumentation for biopharmaceutical process & utilities systems and supports all aspects of the site calibration program. Evaluates new instrumentation for functional equivalence to existing instrumentation. Supports authoring and maintains configuration specifications & standards for cGMP manufacturing instrumentation. As a Senior/Prinicpal Instrumentation Engineer, a typical day might include, but is not limited to, the following: Understanding of common process & utilities instrumentation including but not limited to load cells, pressure transmitters/gauges, pH sensors, dissolved oxygen sensors, temperature sensors, mass flow meters, UV analyzers, conductivity sensors, TOC analyzers and level sensors Evaluating & specifiying cGMP instrumentation for new installations & for the upgrade of existing instrumentation with additional functionality, including instrument components & spare parts Being the technical SME for the site calibration program, providing technical guidance to calibrations operations team and supporting regulatory body inspections and audits. Evaluating new instrumentation for Functional Equivalence to existing instrumentation that has become obsolete Implementing corrective/preventative actions for existing instrumentation Working knowledge of process automation control systems. Conducting troubleshooting and root cause analysis for complex instrumentation and associated systems Creating and maintaining configuration specifications for cGMP manufacturing instrumentation Assisting in the design review of equipment, and approved supplier lists for instrumentation Reviewing and approval of wiring diagrams for instrumentation & associated control systems Preparing engineering evaluations and test plans for change control documentation. Writes and executes test plans to demonstrate instrument suitability Supervising engineering contractors, may be required Maintaining a clean and safe working environment by enforcing procedures, policies, and regulations Maintaining company reputation by ensuring compliance with applicable regulatory authority requirements This role might be for you if: You possess logical troubleshooting and problem-solving skills You have good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally You have strong analytical and organisational skills To be considered for this opportunity you must hold a BEng/BS along with 5+ years experience for Senior Engineer level and 8+ years experience for Principal Engineer level. Experience with Biopharmaceutical Process & Utilities systems is preferred. REGNIRLTO Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! 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 QC Analyst in HPLC Chemistry you will perform a wide variety of chemical or biological analyses on products, in-process materials, or stability samples in support of the company's quality program. In this role a typical day might include, but is not limited to, the following: Gathering data and documenting test results Reviewing test results to ensure compliance with standards and reporting any quality anomalies Complying with all pertinent regulatory agency requirements Participating in required training activities Maintaining laboratory supplies Conducting testing on in-process, product, stability, and/or research samples Writing and revising control test procedures and SOPs Completing test records and reviewing data Calibrating or verifying calibration of instruments/devices prior to use Interacting with outside customers or functional peer groups May be responsible for maintaining a specific project May devise or develop new analytical methods and techniques May assist in validation and method transfer of methods May be involved in establishing the transfer of methodology from R&D This role might be for you if: You have current or prior experience working with HPLC in a regulated environment You enjoy working a shift pattern You have a proven ability to work independently or as part of a team You possess strong trouble-shooting and problem solving skills You have strong attention to detail & excellent written and oral skills To be considered for this opportunity you should have a BS/BA in Life Sciences or related field. Minimum of 2 years' experience in QC. HPLC/UPLC and Empower required. Experience in SE-UPLC, peptide and glycan assay desirable. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! 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.
Within this role you will be responsible for a wide variety of bioanalytical processes to support bulk drug substance manufacture in a cGMP regulatory environment. As a QC Analyst in the Gel's Lab, a typical day might include, but is not limited to the following: Ensuring that all work carried out is in compliance with current GMP, the required regulatory standards, conforms to company policies and standard operating procedures (SOPs) Reviewing data from other analysts for accuracy and completeness Performing gels/separations assays (CE-SDS/SDS-PAGE, iCIEF, PICO MCE, Western Blot) in compliance with cGMP practices Performing data processing using Empower Maintaining laboratory reagents and supplies Preparing reagent aliquots and buffers for use in assays Maintaining equipment in the laboratory Conducting laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT Initiating and completing CAPAs in accordance with site procedures Writing new and updates current SOPs as needed Presenting bioanalytical data reports clearly and concisely to management Identifying and implementing lab process improvements, lean initiatives Performing any other duties relevant to the QC laboratory position as required This role might be for you if: You have current or prior experience working with Gel based Assays You have a proven ability to work independently or as part of a team You possess strong trouble-shooting and problem solving skills You have strong attention to detail & excellent written and oral skills To be considered for this opportunity you must hold a BS/BA in Life Sciences or related field or an equivalent combination of education and experience with 2+ years' experience working in a regulated testing environment. Previous experience working in a regulated Biotech environment is a distinct advantage. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! 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 Manager, Global Development Auditing (GCP) to join our Global Development Quality Assurance (GDQA) team. In this role, you'll play a pivotal part in protecting data integrity and ensuring compliance with Good Clinical Practice (GCP) across Regeneron's clinical programs. You will be responsible for leading audits from start to finish - planning, execution, and reporting - with a particular focus on site investigator audits across Europe. This position offers the opportunity to work globally, collaborate across teams, and serve as a trusted quality leader. A Typical Day: Leading investigator site audits in Europe and the U.S. to assess compliance with GCP standards. Conducting vendor and internal process audits across global operations. Leading the full audit cycle, including preparation, on-site execution, reporting, and follow-up. Interpreting regulations and identifying solutions to complex compliance issues. Partnering with GDQA colleagues and cross-functional teams on quality initiatives. Supporting regulatory inspections as part of the inspection room team. Contributing to staff development by mentoring and sharing procedures. This Role May Be For You If: You have strong experience conducting GCP audits and can expertly lead investigator site audits. You're diligent and take pride in writing clear, high-quality audit reports. You're comfortable balancing independence with cross-functional collaboration. You enjoy solving compliance challenges and applying QMS knowledge to practical solutions. You thrive in a role that combines structure with the variety of international exposure. To Be Considered: You'll need a bachelor's degree and at least 6 years of relevant proven experience, including 4+ years in GCP auditing. Experience leading multiple audit types - especially investigator site audits - is essential. Familiarity with quality management systems (QMS) is required, along with a strong grasp of international regulations. This position requires 30-40% travel across the EU and occasionally the U.S. At Regeneron, we develop an inclusive, diverse culture where everyone's contributions are valued. We offer comprehensive benefits tailored to your location, which may include health and wellness programs, equity awards, annual bonuses, fitness centers, and generous paid time off. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. 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 Clinical Study Lead (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives. This role is not eligible fully remote. This role is required to be onsite in one of our locations. A typical day in this role looks like: Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study Provides operational input into protocol development Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc. Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. Ensures compliance with the clinical trial registry requirements Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors Provides input into baseline budget development and management Provides input into baseline timeline development and management Leads risk assessment and identifies risk mitigation strategies at the study level Leads the feasibility assessment to select relevant regions and countries for the study Oversees/conducts site evaluation and selection Leads investigator meeting preparation and execution Monitors progress for site activation and monitoring visits and acts on any deviations from plan Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan Monitors data entry and query resolution and acts on any deviations from agreed metrics Ensures accurate budget management and scope changes for internal and external studies Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation Escalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issues Oversees the execution of the clinical study against planned timelines, deliverables and budget Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work Ensure clinical project audit and inspection readiness through the study lifecycle Supports internal audit and external inspection activities and contributes to CAPAs as required Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability Contributes to clinical study report writing and review Facilitates and contributes to study level lessons learned Assigns tasks to Clinical Study Management staff and supports their deliverables Recommends and participates in cross-functional and departmental process improvement initiatives Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring 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 May require 25% travel This role may be for you if you have: Exceptional interpersonal & leadership skills Applies advanced expertise and implements the operational strategic direction and guidance for respective clinical studies Demonstrates expert knowledge and a data driven approach to planning, executing, and problem solving Advanced communication skills via verbal, written and presentation abilities Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization Ability to influence and negotiate across a wide range of stakeholders Strong budget management experience An awareness of relevant industry trends Ability to build, lead and develop productive study teams and collaborations Applies advanced negotiation and interpersonal skills to vendor management Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents Knowledge of ICH/GCP and regulatory guidelines/directives Advanced project management skills, cross-functional team leadership and organizational skills Line management experience In order to be considered qualified, a minimum of a Bachelor's degree is required and a minimum of 8 years relevant clinical trial experience. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. 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) $148,300.00 - $241,900.00
The Staff IT Operational Technologist - Splunk plays a pivotal role in delivering high-quality services to end users, with a solid focus on developing, managing, and optimizing reporting processes to support operational excellence in a highly regulated GMP environment. This position requires expertise in Splunk Enterprise and/or Splunk Cloud and the ability to translate sophisticated data into actionable insights. As a Staff IT Operational Technologist - Splunk, a typical day might include the following: Leading the design, development, and deployment of innovative performance dashboards and analytics using Splunk. Building scalable reporting solutions from the ground up, ensuring they meet business objectives and regulatory requirements. Continuously seeking opportunities to improve reporting processes, tools, and methodologies to improve efficiency and accuracy. Implementing automation and advanced analytics techniques to streamline workflows. Analyzing operational data to identify trends, patterns, and actionable insights that drive business decisions. Employing Splunk for real-time monitoring, log analysis, and data visualization in compliance with GMP standards. Ensuring all reporting activities align with regulatory requirements and company policies. Ensuring strict alignment to GMP compliance and regulatory standards in all reporting and data management activities. This role may be for you if you have: Advanced proficiency in Splunk for data visualization, log analysis, and operational monitoring in regulated environments. Certifications as a Splunk Core Certified Power User or a Splunk Core Certified Advanced Power User highly preferred. Strong experience working in highly regulated GxP environments with demonstrable knowledge of compliance requirements. Proven experience in insights, reporting, or performance management roles within major infrastructure-based programs. Expertise in Splunk, Power BI and Tableau, including the ability to design and implement advanced reporting solutions. Solid grasp of SQL scripting and familiarity with Python scripting for data processing and automation. A knack for assessing customer needs, creatively approaching solutions, and influencing appropriate courses of action. In order to be considered for this position, you must hold a BS/BA in Information Technology or related field along with Principal IT Operational Technology Specialist - 8 years of experience delivering IT/OT services to business or consumers. Staff IT Operational Technology Specialist - 10 years of experience delivering IT/OT services to business or consumers. May consider equivalent combination of education and experience. Level is determined based on qualifications relevant to the role. Certifications as a Splunk Core Certified Power User or a Splunk Core Certified Advanced Power User highly preferred. Strong GxP experience and proven experience in highly regulated environments required. Service Management or support in a large-scale and diverse environment of incident management, escalation procedures and related disciplines. Experience with delivering projects and initiatives in the IT or OT space. Deep experience with ITIL disciplines plus experience with operating systems (Microsoft Windows & Linux), VMware and experience with monitoring and security tools such as Splunk, Claroty and next Gen OT tools. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. 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.
Our Medical Affairs physicians and scientists are experts on our medicines and form an extremely valuable part of our global development organization. We serve as an important liaison between Regeneron and the scientific and healthcare community. Medical Affairs is organized in an optimally aligned matrix structure for delivery of therapeutic and functional area expertise. As Regeneron has recently expanded with offices throughout our International locations, we are seeking for a strong leader who is able to manage the Country Medical Directors in these different markets, to develop and execute on local medical affairs strategies to support the Oncology franchise needs in alignment with the Global Medical affairs Oncology Franchise strategies, and adapted to local market needs. For this intent, the role will closely partner with the Oncology Global Medical Affairs Franchise Head and the global Oncology medical leads. Importantly, this role will establish strong partnership with the International Commercial and Market Access Partners and contribute to accelerating the pipeline by supporting our clinical development programs. This leader will cover all markets for the Oncology franchise; direct and indirect; and will also support future pipeline assets as they emerge to address their needs across pre-launch, launch, life cycle management, and in-market. Ability to work with a "start-up mindset" is key as the offices are new and continuing to grow and evolve. The selected individual will work closely with the Heads of Commercial International, Market Access, and Regulatory Affairs, including other key senior leaders within the international organization. A typical day might include the following: Representing Regeneron for International markets, for Oncology Medical Affairs and Clinical Development functions, excluding the USA. Overseeing and evolving a newly formed international medical team, bringing innovation and critical thinking to Medical Affairs processes. Drive Functional excellence for the Integrated Medical teams, ensuring Oncology Teams are working in an integrated and cohesive way to execute with high standard. Advocating for the assessment and allocation of adequate resources to support International medical affairs activities, working closely with the Global Oncology Franchise Head and the Global Oncology Medical Leads. Providing scientific and medical leadership, understanding therapeutic areas, regional/local scientific advancements, disease areas and treatment options to effectively communicate with healthcare providers and other external stakeholders. Contribute to the Global strategies with proper input, as well as gathering meaningful medical insights that will support the Global and local medical affairs strategies. Ensuring countries can deliver and execute local medical plans aligned with global strategies. Establish a close partnership with the Global Franchise Oncology head, to ensure the medical strategies can be understood by the international medical directors and adapted to local needs. Collaborate and align with internal Headquarter colleagues within Global Medical Affairs, Clinical Sciences, Clinical Operations, Regulatory, and Commercial. Ensuring all activities adhere to corporate standards and government/industry regulations. Leading international strategic/operational excellence for Oncology Supporting clinical development and research, identifying medical centers of excellence, and maintaining deep scientific and medical knowledge, in close communication /collaboration with Global Medical affairs team. Engaging and collaborating with external medical experts and medical societies to advance scientific and medical understanding. Acting as an effective Regeneron representative at professional/medical meetings. Providing medical guidance and support to clinical research field operational teams. Assessing medical education needs and developing educational strategies. Ensuring the global team understands local and regional needs to function as a partner in the development of global medical impact plans. Ensuring key external stakeholders are having appropriate engagement collaborating with the local team. Ensuring appropriate training and expertise is maintained at the local level in the direct markets and with key partners in indirect markets. This role is for you if you... are a strategic leader with a breadth of global industry-related experience and strong business acumen. thrive in a multifunctional, matrix organization and can align international activities with global strategies. possess excellent people leadership skills and can foster professional development and growth of direct reports. are a proactive self-starter who can lead work and manage others independently. have strong interpersonal skills, including motivational, negotiation, listening, judgment, analytic, and conflict management skills. can work effectively in a fast-paced, rapidly changing environment and engage in collaborative decision-making. can lead and develop a high-performing medical affairs team, including medical science liaisons (MSLs), providing guidance and support for career development. can develop and implement international medical strategies aligned with Regeneron's overall global strategy, while also considering the specific needs and nuances of international markets. know how to work collaboratively for the interest of the company and impact on patients' lives. know how to bring solutions rather than identifying problems. To be considered, you have a medical degree (Physician, M.D. or equivalent) with commensurate pharmaceutical/biotech industry experience; Medical Affairs experience is required. You have a strong working knowledge of the Medical Affairs and Clinical Development business in Europe, with a thorough understanding of the European healthcare environment. You have 10+ years of oncology/hematology experience in biotech/pharma; other disease areas are a plus. Overall 15+ years of progressive industry/relevant experience. You have a strong background in drug development and life-cycle development of related products. You can manage people and organizations, develop direct reports, and build a strong culture. Experience working in a matrix, cross-functional environment and in alliance relationships is important and helpful. You can cultivate and maintain relationships with key internal and external stakeholders. Significant medical affairs pre-launch and launch experience in major markets (i.e., Europe, Canada, etc.). In addition, you have excellent presentation and communication skills with fluency in English, and you are willing to travel 25-35% of the time. If you are passionate about making a difference in the lives of patients and have the qualifications and skills we are looking for, we encourage you to reach out to us and learn more about this opportunity. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. 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 looking for an International Payroll Analyst to join our team and support payroll operations across Ireland and a range of global locations. In this role, you'll handle a variety of payroll tasks while rotating responsibilities with colleagues to ensure flexibility and coverage. You'll act as a key link between external payroll providers and internal partners, ensuring our payrolls run efficiently, accurately, and in full compliance. This position is ideal for someone with demonstrable experience in global payrolls, a detail-focused mentality, and a passion for maintaining audit-ready processes. A Typical Day: Preparing global payroll inputs across multiple countries with accuracy and timeliness. Partnering with external payroll providers to resolve queries and maintain compliance. Collaborating with Stock, Fleet, Compensation & Benefits, HR Operations, and HR Business Partners on payroll data. Balancing payroll results, reviewing all entries, and submitting for approval. Verifying tax information, reconciliations, and payments before disbursement. Developing time recording and holiday accruals across countries. Responding to employee payroll queries via the shared inbox. Staying current with international payroll legislation and applying updates when needed. This Role May Be For You: You enjoy working with numbers and bring an analytical, diligent approach. You thrive in a collaborative environment, partnering with multiple teams and external providers. You are comfortable rotating responsibilities and adapting to shifting priorities. You like balancing complex data to ensure accuracy and compliance. You keep organized records and naturally maintain an "audit-ready" attitude. You stay informed on legislative changes and take pride in applying them successfully. To Be Considered: You will need a degree in Business, Finance, or Accounting, along with at least three years of experience in international payroll or a similar role. Strong Excel skills, including Pivot Tables and VLOOKUPs, are crucial. Experience with Workday, Core Pay, or Core Insight is an advantage but not required. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. 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. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. 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.
Within this role you will be responsible for the implementation of data governance (DG) standards, policies and procedures into business operations. You will be a site expert on Data Governance, supporting the Regeneron IOPS Data Governance and Integrity program. In this role, a typical day might include the following: Implementing the Data Governance standards, policies and procedures within allocated areas of the business Being the allocated business area(s) key DG contact providing support and advice and engage with the allocated business unit on DG priorities and action plans Assessing allocated business unit's current policies and processes and coordinate the achievement of local KPIs Conducting regular data audits and assessments to identify DG issues and work with business area to prepare for DG auditing and inspections Working with DG Business Partners, Technical Experts, and ECM Experts to deliver the DG plan and provide feedback for continuous improvement Encouraging a culture of quality and Data Governance within the organisation and promoting the importance of DG across all departments Driving communication and collaboration between stakeholders to ensure effective DG practices Encouraging continuous improvement by actively seeking feedback and supporting initiatives designed to improve data quality and governance Leading/supporting initiatives to embed DG principles into the company's core values and everyday practices This role may be for you if: You have knowledge of relevant regulations and guidelines (e.g., GDPR, FDA, EMA, WHO) You have proven success in implementing and managing policies in regulated environments You bring strong communication and collaboration skills You are skilled in stakeholder management and influence You have experience with quality systems and change management To be considered for this role you must hold a BA/BS degree and 7+ years of professional experience or equivalent combination of education and experience in pharmaceutical/FDA regulated work areas such as: data management & operations, quality assurance, compliance, manufacturing operations, quality control, or IT. #JOBSIEST #REGNIRLTO Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. 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're seeking a strategic and scientifically insightful leader to join our Global HEOR team supporting Regeneron's hematologic oncology portfolio. This newly created position within our expanding team you will build us HEOR strategies that help shape clinical development, regulatory decisions, and global market access for novel therapies. In this strategic role, you'll partner with colleagues worldwide to bring significant innovations to patients while influencing the evolving landscape of value-based healthcare. This position can be located in Dublin, Paris, Madrid, Amsterdam, Milan, or Munich, reflecting our expanding European footprint. This hybrid role requires you to be on-site three days a week. If eligible, we can offer relocation benefits. A Typical Day: Developing and implementing global HEOR strategies for our leading hematologic oncology assets. Collaborating with cross-functional partners to strengthen product value propositions and support patient access. Leading design and execution of health economic models, value dossiers, and HTA submissions. Coordinating regulatory-grade real-world evidence studies and innovative RWD partnerships. Guiding development and validation of clinical outcomes assessments for integration into trials. Driving epidemiology analyses and observational studies to support development and commercial goals. Communicating HEOR insights to international teams, HTA bodies, and reimbursement decision-makers. Leading vendors and external experts to ensure high-quality HEOR results. This Role May Be For You: You want to make a meaningful impact on patient lives through your work. You thrive on building evidence strategies that develop regulatory and reimbursement outcomes. Thrive in a fast-paced, collaborative environment. Enjoy a highly visible role that influences critical decisions. You want on ground breaking therapies in malignant hematology and oncology. To Be Considered You will need an advanced graduate degree (Ph.D., MS, MD, PharmD, B. Pharm, or RN with master's) in a HEOR-related subject area such as health economics, outcomes research, health services research, pharmacoepidemiology, epidemiology, or statistics. You should bring 7+ years of HEOR or related experience with a PhD, or 9+ years with an MS, including expertise in study design, health economic modeling, and COA development. Experience engaging with regulatory authorities and HTA agencies is essential, along with a strong publication record. Oncology HEOR experience (minimum 2 years) and familiarity with regulatory-grade RWE are highly preferred. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. 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. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. 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.