The Apprenticeship Programme is designed to provide apprentices with the required knowledge, skills and competencies to perform as a qualified craftsperson. Under the guidance of experienced Technicians, the Apprentice is primarily responsible to provide a support service to the site as part of the Facilities team specialising in OEM Apprenticeship activities. The successful candidate will complete all training, both on and off site phases as per SOLAS OEM Apprenticeship training programme curriculum. A typical day might include, but is not limited to, the following: Under the guidance of experienced Technicians: Providing support to Facilities, Quality Assurance, Automation, Engineering, Operations or any other area as required Installing, testing, servicing and maintaining a range of engineered equipment Assembling, installing, testing, commissioning, and carrying out fault diagnostics on electrically powered systems Completing both scheduled and unscheduled maintenance activities on plant and equipment Following site Environmental, Health and Safety policies and striving to maintain an accident-free environment Ensuring documentation of maintenance activities to current GxP standards both in paper-based records and the computerised maintenance system Maintaining the physical condition and environment of all areas Supporting continuous improvement, housekeeping and Lean initiatives Working across all areas of Facilities Contributing to the development of the apprenticeship programme at Regeneron This role might be for you if: You are interested in engineering and mechanical systems You possess logical troubleshooting and problem-solving skills You enjoy hands-on tasks and have a dynamic approach to work You are willing to participate in off-the-job college phases over three years To be considered for this opportunity you must have a Leaving Certificate, including a pass in Maths and a Science or Engineering subject. #REGNIEEC #REGNIRLTO #JOBSIEST 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 involved in start-up, normal operation, monitoring & shutdown, and maintenance of clean utilities, grey utilities and HVAC. This will include WFI, clean steam, bulk gases, bulk chemicals, process water generation, boilers, chillers, chemical dosing systems, cooling towers, air compressors, LPHW skids, waste water treatment, biowaste inactivation skids, HVAC system for cleanrooms and other mechanical equipment to provide utilities for buildings or industrial processes. The successful candidate will be required to work 24/7 shift which includes day & night shift. A typical day might include, but is not limited to, the following: Working on the daily operation and maintenance of a wide variety of HVAC, clean and grey utilities equipment in a modern GMP facility Diagnosing and resolving problems with utility systems and equipment Conducting routine inspections and preventative maintenance to ensure the reliable operation of systems and equipment Maintaining records of operation, maintenance, and safety activities, including test results, instrument readings, and details of equipment malfunctions and maintenance work Switching from automatic to manual controls and isolating equipment mechanically and electrically to allow for safe inspection and repair work Following safety procedures, including COHE, lockout/tagout, and handling hazardous materials when necessary Observing & interpreting readings on gauges, meters, and charts registering various aspects of utilities operation to ensure that equipment is operating properly Using the Building Automation Systems (BAS) to monitor and inspect equipment, computer terminals, switches, valves, gauges, alarms, safety devices, meters to detect leaks or malfunctions and to ensure that equipment is operating efficiently and safely Performing or arranging repairs, such as complete overhauls, replacement of defective valves, gaskets, bearings, or fabrication of new parts Operating facilities equipment and auxiliary equipment such as pumps, compressors, and air-conditioning equipment, to supply and maintain steam or heat for buildings and to meet industrial processes Testing boiler water quality or arrange for testing and take necessary corrective action, such as adding chemicals to prevent corrosion and harmful deposits Monitoring boiler water, chemical, and fuel levels, to make adjustments to maintain required levels Contacting equipment manufacturers or appropriate specialists when necessary to resolve equipment problems Controling and maintaining HVAC systems to support cleanroom environments This role might be for you if: You enjoy working collaboratively within a team You are self-sufficient and can manage responsibilities independently You possess logical troubleshooting and problem-solving skills You have a good understanding of utility systems and manufacturing equipment You are comfortable performing tasks with minimal supervision You want to expand your professional expertise in a regulated environment To be considered for this opportunity you should be qualified to National Craft Standard with a minimum of 2+ years' experience in a similar role. Will substitute additional relevant experience for educational requirement. #REGNIRLTO #JOBSIEST 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. 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 Director, Patient Safety Intake and Regulatory Submissions delivers Global Patient Safety (GPS) Department services according to ICH-GCP guidelines, regulatory requirements and Regeneron standard operating procedures (SOPs) and/or project specific procedures. This position is responsible for the oversight of the processes and systems which enable initial Intake of adverse event data (i.e., via electronic database capture (EDC), phone line, etc.), the subsequent reporting of Individual Case Safety Reports (ICSRs) to health authorities, Alliance Partners and internal destinations in compliance with applicable global regulations (ICH-GCP) and contractual obligations, and follow up activities to ensure receipt complete and accurate safety information. This role will lead a global team responsible for all aspects of Intake and ICSR submissions for the company product portfolio covering pre and post marketing activities. This position will also be responsible for the oversight and maintenance of all reporting rules in the global safety database, Argus. In this role, a typical day might include: ICSR Intake and Submissions from all sources to all applicable destinations. This includes, but is not limited to expert knowledge of tools and systems that allow for data automation, advanced data validation, and analytics Oversight of all aspects of Intake responsibilities for ICSRs, including management of applicable vendors. Oversight of all aspects of ICSR submission including database configuration and assessment of study particulars and reporting requirements across current global regulations and approval of configuration requests Provides input into contract deliverables to support outsourced Intake and Submissions activities as well as assist with the review, execution, and implementation of related contract deliverables Oversight of the all follow up activities including but not limited to the issuance of targeted follow questionnaires associated with risk management plans or other routine safety data monitoring measures and obigations Review and/or creation of metrics to measure intake and reporting compliance to regulatory agencies, Alliance Partners, internal destinations and contract research organizations Training and mentoring of staff on safety information pertaining to Intake and ICSR submission processes Serve as ICSR Intake and Submission subject matter expert (SME) for audits and inspections Ability to further develop and maintain best practices/processes for high quality and compliant Point of contact for queries from external or internal stake holders. Performs other related duties as assigned or requested per business needs. This role might be for you if you can/have: Independently identify, analyze, and problem solve moderate to complex issues and trends. Strong knowledge of clinical research process and global pharmacovigilance regulations, systems, and processes. Previous people management experience with the ability to mentor and develop direct reports. Strong knowledge of intake and reporting platforms, tools, and systems (i.e. LifeSphere Advanced Intake, PVIT, etc.) Thorough understanding of the global regulatory requirements and the importance of compliance with procedural documents and regulations. Excellent written and verbal communication skills. Able to express complex ideas. Able to develop knowledge of protocol, regulatory requirements, and company SOPs. Able to identify and document regulatory non-compliance and any related issues. Excellent organizational and interpersonal skills. Ability to reason independently to assess and recommend specific solutions in a clinical setting. Attention to detail; able to identify and resolve discrepancies on compliance reports. Demonstrates professionalism and presents a positive image of the company. Demonstrates excellence in customer service, both internally and externally. Demonstrates commitment, dedication, cooperation, positive behavior, adaptability and flexibility with changes in responsibilities and duties. Demonstrates honesty and integrity in dealing with others. Works effectively with different types of people. Establishes and maintains effective relationships with customers (internal and external) and gains their trust and respect. Ability to organize, plan and execute projects, including the ability to delegate and guide the work of others to achieve project completion timelines and quality standards. To be considered for this opportunity, you must have the following: Bachelor's Degree in one of the life sciences or clinical research and/or a licensed healthcare professional required. Minimum of 12 years of experience in safety and safety reporting. Equivalent combination of relevant education and experience. Computer literacy and experience working with Microsoft Office (Word, Excel, PowerPoint) required Excellent knowledge of Argus and its applications. Excellent verbal and written communication skills required. Excellent interpersonal and organizational skills required. Ability to work independently, prioritize effectively and work in a matrix team environment required. Ability and willingness to travel domestically as required; ability to rent automobile. 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) $180,400.00 - $300,700.00
As an Automation Process Engineer you will be responsible for providing an advanced level of technical and automation support to manufacturing. A typical day might include, but is not limited to, the following: Providing advanced level of technical and automation support to manufacturing Preparing performance monitoring reports for automated systems used in commercial manufacturing Performing investigation manufacturing deviations and anomalies related to automation and software Implementing software changes and upgrades Managing small projects related to corrective action or equipment performance improvement Implementing modification/change control procedures and protocols Supporting Validation Department with initial design review, software testing, and protocol review Providing direction to junior employees and/or contractors within department This role might be for you if: You have strong analytical and organisational skills You are able to prioritise and re-prioritise as needed and adapt to change You are comfortable working in a fast-paced setting To be considered for this opportunity you should have a Bachelor's degree in Computer Science or a similar field of study. Engineer requires 3+ years relevant experience. Senior Engineer 5+ years of relevant experience. #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 Sr. Manager Global Procurement-R&D you will be responsible to support and assist in the development and implementation of the Clinical Category Management strategy. We proactively manage a supply base and enhance value, minimize risk, and ensure quality & cost effectiveness by working collaboratively with our business units. For US locations (Armonk, Tarrytown, Sleepy Hollow in NY or Basking Ridge, 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 typical day may include the following: Collaborates to manage discussions related to the strategies and aligns category priorities with Procurement management and team members. Manages negotiations, supplier management activities, and partner engagement activities. Takes direction to drive value in terms of cost savings, cash flow improvement, and other efficiency savings from category management activities. Represents Global Procurement by participating in organizational decisions with critical short and long-term impact on the success, efficiency, growth, and results. Demonstrates knowledge within the biopharmaceutical industry to drive improvements aligned with corporate priorities. Manages category activities to ensure compliance with appropriate GxPs and other applicable regulations, as applicable. Negotiates contract terms and conditions in consultation with Law department aligned with our priorities and business requirements. May, either directly or through a matrix structure, manage team of professional level employees responsible for performing category management tasks. May provide coaching and guidance on job performance and career development to direct reports (if applicable) and provides leadership examples for the organization. Uses data to drive decision-making for successful category projects. This may be for you if you: Can demonstrate strong relationship management capabilities with collaborators and suppliers. Want to have an impact on patient lives. Are experienced in supporting a global supply market evaluation processes using market intelligence, risk, compliance, and financial assessment tools. Operate with integrity, focus, and clarity in an environment of ambiguity to inspire change and improvement. To be considered it is required to have a Bachelor's degree in a relevant field of study plus relevant, progressive experience in procurement, including experience in the Pharmaceutical industry. Experience successfully with category processes, and suppliers across a breadth of categories. Experience demonstrating success working effectively with cross-functional teams to get results in Global Clinical Category strategies through effective sourcing, negotiations, contracting, and supplier relationship management. Have provided insights and knowledge regarding rates, unit costs, and costing structures to enable optimal negotiations. Experience managing associate level professionals 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. Salary Range (annually) $132,400.00 - $216,000.00
Within this role you 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 an Automation Engineer a typical day might include, but is not limited to, 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 Working on equipment ranging from standalone equipment such as UV Specs, pH meters, particle samplers to networked equipment such as wave rockers, chromatography skids and cell analysers Overseeing and execution 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, understands impact of actions to manufacturing and facilities Providing assistance prior to, during and post regulatory/partner inspections Supporting automation change control requests Participating in or may lead small manufacturing equipment projects to introduce new equipment or upgrade existing applications Working with validation and quality departments to ensure automation applications associated with small manufacturing equipment are implemented following development life cycle approach Participating in or may lead small manufacturing equipment applications, security access and periodic audit trail reviews This role might be for you if: You have relevant experience in Automation or IT You are innovative, possess high attention to detail and results driven You possess an ability to operate as part of a team in a highly interdependent environment You have excellent analytical, written and oral communication skills To be considered for this opportunity you should have a BS/BA or higher in Automation, Information Technology, or related field with 5+ years relevant experience. #REGNIRLTO #JOBSIEST 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 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 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 #GDPSJobs 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) $202,000.00 - $336,600.00
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 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 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) $202,000.00 - $336,600.00
Within this role you 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 an Automation Engineer a typical day might include, but is not limited to, 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 Working on equipment ranging from standalone equipment such as UV Specs, pH meters, particle samplers to networked equipment such as wave rockers, chromatography skids and cell analysers Overseeing and execution 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, understands impact of actions to manufacturing and facilities Providing assistance prior to, during and post regulatory/partner inspections Supporting automation change control requests Participating in or may lead small manufacturing equipment projects to introduce new equipment or upgrade existing applications Working with validation and quality departments to ensure automation applications associated with small manufacturing equipment are implemented following development life cycle approach Participating in or may lead small manufacturing equipment applications, security access and periodic audit trail reviews This role might be for you if: You have relevant experience in Automation or IT You are innovative, possess high attention to detail and results driven You possess an ability to operate as part of a team in a highly interdependent environment You have excellent analytical, written and oral communication skills To be considered for this opportunity you should have a BS/BA or higher in Automation, Information Technology, or related field with 5+ years relevant experience. #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.
