A leading biopharmaceutical company is seeking an experienced Regulatory Affairs Manager in Ireland. You will be instrumental in ensuring compliance with EU regulations, developing regulatory strategies for clinical approvals, and leading activities for MAAs. Ideal candidates will possess an advanced scientific degree, at least 5 years in regulatory affairs, and a strong background in EU systems. This role emphasizes collaboration with cross-functional teams and offers a dynamic working environment with a solid commitment to compliance and innovation. #J-18808-Ljbffr
A leading biotechnology company is hiring a Medical Director, Field Medical Affairs (Rare Diseases) to drive innovation in healthcare. This hybrid role involves leading scientific discussions, evaluating health technology, and collaborating across functions in Europe. Candidates should have an advanced degree and 12+ years of experience in clinical practice or pharmaceuticals, with a passion for improving patient outcomes and may require travel up to 50%. A supportive and inclusive work environment with comprehensive benefits is offered. #J-18808-Ljbffr
At Regeneron, we believe that when the right idea finds the right team, powerful change is possible. As we work across our growing global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. We are looking for an experienced and motivated Regulatory Affairs Manager to join our team in either Dublin or London. In this pivotal role, you will bring your EU-specific regulatory expertise to support our development programs and ensure compliance with emerging EU legislation. This is a 12-month contract. A Typical Day: Develop and implement EU-appropriate regulatory strategies for clinical development and product approvals. Provide leadership on both late- and early-stage clinical development processes to ensure timely study conduct. Lead regulatory activities for clinical study start-up and maintenance, including submissions and addressing agency queries. Oversee Marketing Authorization Application (MAA) processes to secure timely product approvals with competitive labelling. Monitor and interpret emerging EU legislation and guidance, ensuring company-wide awareness and compliance. Serve as a key resource for EU regulatory knowledge to support global regulatory and development teams. This Role May Be For You If: You have a strong understanding of EU regulatory systems and processes. You excel at developing and executing regulatory strategies for clinical development. You are detail-oriented and adept at managing compliance issues and agency interactions. You enjoy collaborating with cross-functional teams and external collaborators. To Be Considered: You must hold an advanced degree in a scientific field (Master’s Degree or Ph.D.) and have at least 5 years of experience in regulatory affairs. Experience with EU regulatory systems, clinical development processes, and working with EMA or EU National Agencies is important. Preferred applicants will have a strong background in respiratory or inflammation therapeutic areas and a proven ability to collaborate with business partners and cross-functional teams. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels. For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S., Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications, etc. #J-18808-Ljbffr
Associate Biotech Production Specialist Join to apply for the Associate Biotech Production Specialist role at Regeneron . Responsibilities Work as part of the Manufacturing team to carry out tasks in line with the production schedule as directed by Team Leads and Supervisors. Monitor production processes. Participate in equipment start‑up, commissioning and validation activities. Assist with troubleshooting in case of equipment failure. Perform manufacturing‑level maintenance on equipment. Adhere to safety and GMP requirements at all times when carrying out tasks. Perform equipment cleaning, preparation and execution as well as complete associated documentation. Perform various tests and in‑process sampling. Review, edit and revise completed batch records, logbooks and SOPs in accordance with cGMP standards. Maintain housekeeping in designated area and adhere to the clean standards of the facility. This Role Might Be For You You possess excellent verbal and written communication skills. You enjoy problem solving. You demonstrate a can‑do attitude. You are proficient in Microsoft Word, Excel, PowerPoint and Outlook. You demonstrate an ability to work effectively within a team. You adapt to a changing environment and can adhere to a schedule. Requirements To be considered for this opportunity you should have a BS/BA in Life Sciences or a related field. Relevant experience may be substituted in lieu of the educational requirement. Compensation and Benefits Competitive salary Shift premiums Annual bonus Stock schemes Employer pension contributions Education assistance Generous annual & flexible leave programs Competitive private medical, dental & vision plans Career & personal development Wellness programs – onsite gyms & fitness classes Concierge services – onsite beauty therapist / barber / car valet Community volunteering Employee interest groups / teams & clubs Employee & family events 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 for 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. #J-18808-Ljbffr
A leading biotech company based in Limerick is seeking an Associate Biotech Production Specialist to join their Manufacturing team. In this role, you will monitor production processes, participate in equipment start-up, and perform maintenance alongside adhering to safety and GMP requirements. Candidates should have a BS in Life Sciences or related field, with relevant experience considered. This position offers competitive salary and a range of benefits including bonuses, stock schemes, and wellness programs. #J-18808-Ljbffr
Principal Automation Integration Engineer 1 day ago Be among the first 25 applicants We are seeking a highly skilled, experienced software Integration Engineer with experience in real-time data collection and analysis to join a diverse team of engineers, developers, analysts, and administrators to design, implement and support Data Acquisition and Analysis Systems. Typical Day Designing, developing, and implementing software/hardware improvements to existing automated equipment and new equipment according to change control procedures. Integration of industrial automation systems, business applications and enterprise data platforms. Performing troubleshooting and investigations relating to manufacturing deviations and anomalies associated with automated control systems. Developing and editing engineering design documents, technical evaluations, and test plans for cGMP process equipment while following GAMP 5 guidelines. Supporting small manufacturing, engineering, and validation projects. Providing support to process control and process monitoring equipment software design, commissioning, testing, and corrective action. Authoring or updating system specifications, user and functional requirements specifications, generating and executing vital Factory Acceptance Tests (FAT) and Site Acceptance Testing (SAT) protocols. Reviewing cyber security vulnerabilities and risk pertaining to automation systems, software, and infrastructure. Creation, modification, and maintenance of automation system documentation. Qualifications Experience with OT applications, including SCADA, HMI, Historians, etc. Experience with advanced technologies such as OPC UA, MQTT, IIOT platforms, and data integration tools to create a centralized, real-time data architecture that supports Industry 4.0 initiatives. Familiarity with standing up large systems at the enterprise level. Core knowledge related to ISE S95, S88 principles and IT/Automation integration. Familiarity with PLC communication, HMIs, computerized system design and maintenance of automation process control infrastructure. Ability to challenge the status quo and champion continuous improvement. Enjoy project-oriented work with the goal of being an expert in keeping a biopharmaceutical process running smoothly. Can balance changing priorities with increasing workload by making and communicating timely decisions. Education & Experience To be considered for this position, you ideally should have a Bachelor's Degree in Computer Science, Chemical, Mechanical, or Electrical Engineering and the following minimum years of relevant experience: Senior Engineer: 5+ years Principal Engineer: 8+ years Benefits We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit Regeneron Careers page. For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. Many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. Seniority Level Mid-Senior level Employment Type Full-time Job Function Engineering and Information Technology Biotechnology Referrals increase your chances of interviewing at Regeneron by 2x Location Limerick, County Limerick, Ireland #J-18808-Ljbffr
A leading biopharmaceutical company in Limerick is searching for a Principal Automation Integration Engineer. The candidate will design and implement systems while troubleshooting automated control deviations. With a Bachelor's degree and at least 5 to 8 years of experience required, this role promotes a continuous improvement mindset and offers an engaging project-oriented work environment. Full-time position emphasizes collaboration on-site with diverse teams. #J-18808-Ljbffr
Senior/Principal Instrumentation Engineer Join to apply for the Senior/Principal Instrumentation Engineer role at Regeneron Senior/Principal Instrumentation Engineer 2 weeks ago Be among the first 25 applicants Join to apply for the Senior/Principal Instrumentation Engineer role at Regeneron Get AI-powered advice on this job and more exclusive features. 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 #IREADV #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.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Engineering and Information Technology Industries Biotechnology Referrals increase your chances of interviewing at Regeneron by 2x Get notified about new Senior Instrumentation Engineer jobs in Limerick, County Limerick, Ireland . Senior / Principal Instrumentation Engineer Limerick, County Limerick, Ireland 2 weeks ago Limerick, County Limerick, Ireland 1 week ago Limerick, County Limerick, Ireland 1 week ago Limerick, County Limerick, Ireland 1 week ago Limerick, County Limerick, Ireland 2 weeks ago Limerick, County Limerick, Ireland 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
We’re hiring a Medical Director, Field Medical Affairs (Rare Diseases) to help advance care in cardiovascular, muscle, and bone conditions. This hybrid role blends strategic medical planning with field-based scientific engagement across select European countries. You’ll join a collaborative international team focused on launching innovative therapies and strengthening partnerships that improve patient outcomes. If you’re motivated by scientific excellence and the opportunity to shape rare disease care, we’d love to hear from you. A Typical Day: Leading scientific discussions with healthcare professionals and key opinion leaders. Evaluating health technology assessments, reimbursement pathways, and market access strategies. Responding to medical inquiries with accuracy and regulatory compliance. Collaborating across functions to support speaker training and promotional review. Sharing field insights to inform medical planning and product development. Supporting post-approval clinical trials from design to reporting. Partnering with CRO medical monitors and study teams to enhance site engagement. This Role May Be For You If: You’re a strategic problem solver who thrives on connecting science with real-world impact. You enjoy building trusted relationships and engaging in scientific dialogue. You’re comfortable navigating complexity and making informed decisions in dynamic environments. You take pride in translating clinical data into clear, actionable insights. You’re driven to advance rare disease innovation and improve patient outcomes. You’re adaptable and confident managing travel and engagement across diverse European healthcare systems. To be considered, you’ll need an advanced clinical or scientific degree (MD, DO, PharmD, or PhD) and at least 12 years of experience in clinical practice, managed care, or the pharmaceutical industry, including a minimum of two years in Medical Affairs. Experience as a Medical Science Liaison or in a similar role is a plus. You must reside within the designated territory and be able to travel up to 50%. Fluency in English is required. We encourage candidates with experience launching rare disease therapies, contributing to clinical trial design, and proficiency in French, Spanish, Italian, or German. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. #J-18808-Ljbffr
Join to apply for the Facilities Engineer/Sr Engineer role at Regeneron Continue with Google Continue with Google 2 weeks ago Be among the first 25 applicants Join to apply for the Facilities Engineer/Sr Engineer role at Regeneron Within this role you will be responsible for providing engineering support, troubleshooting, subject matter expertise to the Facilities Operations, Utilities and HVAC teams. You will be designing, specifying and commissioning new and renovated biopharmaceutical utilities and HVAC equipment, managing small to mid sizes projects relating to utilities and HVAC equipment & services. As a Facilities Engineer, a typical day might include, but is not limited to, the following: Designing and specifying cGMP clean/grey utilities, & HVAC equipment, piping, ducting and/or controls Managing small-to-mid sized projects related to utilities and HVAC equipment and services Conducting troubleshooting for complex issues with plant equipment issues and associated systems, identifying and recommending corrective actions Assisting in the design review, site acceptance and installation of equipment Supporting the QA validation department by preparing design documents and assisting in protocol execution Assisting in investigations of utility systems, and control system anomalies as well as safety incidents Implementing corrective/preventative actions for existing equipment and maintenance processes Preparing engineering evaluations and test plans for and executing modification change control documentation Interpreting P&IDs, equipment/system layouts, wiring diagrams and specifications in planning and performing maintenance and repairs Supervising mechanical, electrical, and automation contractors Maintaining a clean and safe working environment by enforcing procedures, policies, and regulations Maintaining company reputation by enforcing compliance with all relevant laws, policies and regulations 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 level 8 within an engineering discipline or equivalent with 3+ years of experience in engineering preferred. For the Senior Engineer you must have 5+ years relevant industry experience. Direct experience with Utilities systems (clean / grey) or HVAC is preferred. #REGNIRLTO #IREADV #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.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Management and Manufacturing Industries Biotechnology Referrals increase your chances of interviewing at Regeneron by 2x Sign in to set job alerts for “Senior Facilities Engineer” roles. Continue with Google Continue with Google Continue with Google Continue with Google Limerick, County Limerick, Ireland 4 weeks ago Shannon, County Clare, Ireland 3 weeks ago Shannon, County Clare, Ireland 2 weeks ago Sr Advisor – Program Manager – Global Facilities Delivery Limerick, County Limerick, Ireland 2 weeks ago Limerick, County Limerick, Ireland 2 weeks ago Limerick, County Limerick, Ireland 2 weeks ago Limerick, County Limerick, Ireland 3 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
