Ein globales Pharmaunternehmen in Dublin sucht einen Senior Manager für Regulatory Affairs. In dieser Rolle sind Sie verantwortlich für das Management globaler Regulierungsstrategien und die Sicherstellung der Compliance in allen Märkten. Die Anforderungen umfassen umfangreiche CMC-Autorenerfahrung, Kenntnisse der regulatorischen Anforderungen, sowie hervorragende Kommunikationsfähigkeiten. Sie haben die Chance, in einem dynamischen Umfeld mit einem engagierten Team zu arbeiten, das darauf abzielt, die Gesundheitsversorgung weltweit zu verbessern. #J-18808-Ljbffr
Una empresa farmacéutica global busca un Senior Manager en Regulatory Affairs para asegurar el cumplimiento regulatorio global y liderar estrategias regulatorias en proyectos de desarrollo de medicamentos. Buscamos un candidato con experiencia en autoría CMC y habilidades avanzadas en comunicación. La posición ofrece un ambiente inclusivo, oportunidades de progreso en la carrera y un paquete de compensación competitivo. #J-18808-Ljbffr
Ein führendes Pharmaunternehmen in Irland sucht einen Quality Systems Specialist, der Qualitätssysteme entwickelt und implementiert sowie sicherstellt, dass regulatorische Anforderungen erfüllt werden. In dieser Rolle arbeiten Sie eng mit verschiedenen Abteilungen zusammen, um die Qualität von Produkten und Prozessen zu verbessern. Der ideale Kandidat hat mindestens 3 Jahre Erfahrung in der Branche und Kenntnisse der EU- und US-Vorgaben. Wir bieten ein wettbewerbsfähiges Gehalt und ein unterstützendes Arbeitsumfeld. #J-18808-Ljbffr
Senior Specialist Regulatory Key Initiatives page is loaded## Senior Specialist Regulatory Key Initiativeslocations: Northern Cross, Dublin, Irelandtime type: Vollzeitposted on: Heute ausgeschriebenjob requisition id: R5668374McDermott Laboratories LimitedViatris ist ein globales Gesundheitsunternehmen, das einzigartig positioniert ist, die traditionelle Kluft zwischen Generika und Marken zu überbrücken und das Beste von beiden zu verbinden, um weltweit umfassendere Gesundheitsbedürfnisse zu adressieren. Mit der Mission, Menschen weltweit zu befähigen, in jeder Lebensphase gesünder zu leben, bieten wir Zugang in großem Maßstab, liefern derzeit jährlich etwa 1 Milliarde Patienten weltweit hochwertige Medikamente und berühren alle Lebensmomente – von der Geburt bis zum Lebensende, von akuten Erkrankungen bis hin zu chronischen Krankheiten. Wir wurden auf zahlreiche Auszeichnungslisten aufgenommen, die die Wirkung zeigen, die wir erzielen. Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.**The Role & What You Will Be Doing**The **Senior Specialist, Global Regulatory Operations** key will be responsible for utilizing their SME Regulatory knowledge to stay proactively informed of key regulatory initiatives across the globe, with a focus on pan European regulations. This will include a detailed impact and change management assessment on Regulatory business processes and systems to ensure that they are fit for purpose and changes are clearly communicated to all those impacted. Examples of key initiatives include eCTD 4.0, ePI, and IDMP.Every day, we rise to the challenge to make a difference and here’s how the **Senior Specialist, Regulatory Key Initiatives** role will make an impact:* Monitor and interpret global regulatory initiatives, with a strong focus on EU regulations (e.g. IDMP, eCTD 4.0, SPOR), ensuring the organisation remains compliant and informed.* Lead cross-functional collaboration to identify data owners, improve data governance, and support IDMP implementation.* Act as a subject matter expert (SME) on regulatory data, partnering with stakeholders to define, source, and maintain high-quality data, including establishing QC processes.* Drive data management and enrichment activities, including populating IDMP templates and supporting internal RIM systems and external databases (e.g. EMA PMS).* Identify, prioritise, and resolve data discrepancies, proposing solutions and ensuring visibility through appropriate escalation.* Develop and improve business processes and SOPs, ensuring clear ownership (RACI), efficient workflows, and regulatory compliance.* Support system and process improvements within RIM and related platforms, aligning with evolving regulatory requirements.* Contribute to change management and training initiatives, supporting adoption of new processes, systems, and regulatory standards.* Collaborate with Regulatory Operations, Master Data, and other teams to ensure data alignment, consistency, and integration across systems.**About Your Skills & Experience**For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:* Bachelor’s degree (or equivalent) with pharmaceutical industry experience, preferably in Regulatory Affairs or Regulatory Operations.* Strong knowledge of EU regulatory frameworks, including EMA procedures, XEVMPD, and working knowledge of IDMP and SPOR.* Experience with Regulatory Information Management (RIM) systems and understanding of the eCTD structure.* Ability to interpret complex regulatory and technical documentation, including labelling (e.g. SmPC) and eCTD modules.* Strong organisational skills, with the ability to manage multiple projects and deadlines simultaneously.* Comfort working with complex systems and IT tools, including document and data management platforms.* Excellent attention to detail and a proactive, continuous learning mindset.* Strong collaboration and communication skills, with the ability to work cross-functionally and present complex information clearly.* Proficiency in Microsoft Word and Excel; experience with document management systems is advantageous.At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.**Benefits at Viatris**At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Some of our benefits include the following on top of a competitive salary:* Excellent career progression opportunities* Work-life balance initiatives* Bonus scheme* Health insurance* Pension**Diversity & Inclusion at Viatris**At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit**Sustainability at Viatris**Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visitBei Viatris, bieten wir wettbewerbsfähige Gehälter, Sozialleistungen und ein integratives Umfeld, in dem Sie Ihre Erfahrungen, Perspektiven und Fähigkeiten einsetzen können, um das Leben anderer zu beeinflussen. #J-18808-Ljbffr
Associate Manager, Environmental Health and Safety page is loaded## Associate Manager, Environmental Health and Safetylocations: Northern Cross, Dublin, Irelandtime type: Temps pleinposted on: Offre publiée aujourd'huijob requisition id: R5666648McDermott Laboratories LimitedChez Viatris, nous envisageons la santé non pas telle qu'elle est mais telle qu'elle devrait être. Nous agissons avec courage et notre positionnement unique est source de stabilité dans un monde où les besoins en matière de santé sont en constante évolution. Viatris permet à chacun dans le monde entier de vivre en meilleure santé à chaque étape de sa vie. Via trois axes majeurs:*Accès*: En fournissant des médicaments de haute qualité et reconnus, quels que soient le lieu de résidence ou la situation de chaque patient.*Leadership*: En favorisant l’évolution de nos activités de façon durable et le développement de solutions innovantes pour améliorer la santé des patients.*Partenariat*: En valorisant notre expertise collective afin de donner accès à tous à nos produits et services.Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.**The Role & What You Will Be Doing**The purpose of this role is to Manage the EHS agenda for the Viatris Northern Cross Global Device Development Group & Office Location. The role involves the development, implementation and maintenance of comprehensive EHS Programs which ensure compliance with internal and external EHS requirements and continual improvement in EHS Performance. The primary focus of the role is to keep our people safe and protect the environment in which we operate.Every day, we rise to the challenge to make a difference and here’s how **EHS Associate Manager** role will make an impact:* Develop and implement EHS programs & procedures to ensure continuous compliance with local legislation, Viatris Technical Requirement and industry best practice* Engaging and communicating with Leadership at the location to ensure EHS responsibilities are fully discharged* Manage Emergency Response Planning for the location ensuring the location Emergency Response Plan is maintained up to date, regularly tested and role holders are suitably trained. Ensure all procedures are followed, post‑incident reports are completed and documented, and all corrective actions are tracked and followed up.* Conduct regular internal audits and EHS walk-arounds ensuring the identification of practical and workable solutions to deficiencies raised* Ensure all employees have the necessary information instruction and training in order to conduct their roles in a safe and environmentally responsible manner and ensure all EHS information is easily accessible and maintained up to date.* Lead the investigation of EHS incidents to identify root causes and develop effective corrective action plans* Oversee the implementation of waste reduction and recycling programs, energy efficiency programs and other programs to minimise the environmental footprint of the location* Co-ordinate the risk assessment program ensuring EHS hazards are identified and assed for all activities and tasks conducted at the Location* Co-ordinate the Global Device Development Group testing laboratory safety program* Develop and issue regular communications to ensure continued awareness and engagement on EHS matters* Work with Facilities Team to ensure statutory inspections and other EHS inspections are completed as required* Establish and maintain an employee consultative forum for the location- Safety Committee, EHS Council* Lead and champion the Viatris Incident Prevention Opportunity IPO program for the location* Support the design review and approval of any proposed changes to the building layout or structure ensuring adequate assessment and mitigation of potential impacts to EHS* Co-ordinate the contractor safety program for the location to ensure contractor activities are managed safely and in accordance with regulatory requirements* Promoting a safety culture amongst colleagues at Northern Cross through safety events and activities* Ensure First Aid Training Compliance, including maintaining an up‑to‑date list of trained first aiders, monitoring certification expiry dates, and coordinating timely refresher training to meet statutory requirements.* Manage Ergonomics Assessments, including coordinating ergonomic evaluations, tracking recommended actions, supporting implementation, and monitoring effectiveness to reduce musculoskeletal risks.* Maintain and update the site Safety Statement, ensuring it accurately reflects current operations, risks, and controls, and that it is communicated, accessible, and reviewed in line with legal and corporate requirements.* Ensure all site safety signage is maintained, accurate, and clearly displayed, including Emergency Response Team (ERT) listings, First Aider name listings, first aid equipment, emergency equipment signage, and statutory notices, and ensure updates are made promptly when personnel or site requirements change.**About Your Skills & Experience**For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:* Bachelor’s degree or equivalent in Science/Engineering with 1-2 years’ experience in pharmaceutical and/or medical device development or similar role.* Knowledge of VDU Workstation Assessor and Manual Handling Instructor* **The role requires a 4 day per week physical presence onsite at Northern Cross*** Excellent oral and written communication skills At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.**Benefits at Viatris**At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Some of our benefits include the following on top of a competitive salary:* Excellent career progression opportunities* Work-life balance initiatives* Bonus scheme* Health insurance* Pension**Diversity & Inclusion at Viatris**At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit**Sustainability at Viatris**Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visitChez Viatris, nous proposons des salaires compétitifs, des bénéfices et un environnement inclusif au sein duquel vous pouvez mettre à profit votre expérience, vos perspectives et vos compétences pour aider à avoir un impact positif sur la vie des autres.Viatris est une entreprise mondiale de services de santé créée en 2020 par la combinaison de Mylan et Upjohn, #J-18808-Ljbffr
Global Business Partner Master Data Analyst (1 year fixed term) page is loaded## Global Business Partner Master Data Analyst (1 year fixed term)locations: Northern Cross, Dublin, Ireland: Poland Remote Officetime type: Vollzeitposted on: Heute ausgeschriebenjob requisition id: R5668107McDermott Laboratories LimitedBei VIATRIS, sehen wir das Gesundheitswesen nicht so, wie es ist, sondern so, wie es sein sollte. Wir handeln entschlossen, und unsere einzigartige Positionierung sorgt für Stabilität in einer Welt, in der sich die Bedarfe im Gesundheitswesen stets verändern. Viatris befähigt Menschen in allen Teilen der Welt, in jeder Lebensphase gesünder zu leben. Dies erreichen wir durch:*Zugang* – Zugang zu hochwertigen, bewährten Arzneimitteln und Impfstoffen sowie auch neu entwickelten Biosimilars für Patienten in allen Lebensumständen weltweit*Führungsverantwortung* – Verbesserung der Patientengesundheit durch zukunftsgerichtete nachhaltige Unternehmensführung und innovative Lösungen*Partnerschaft* – Optimaler Einsatz unserer Kompetenzen, um Menschen den Zugang zu Produkten und Dienstleistungen zu ermöglichen.Every day, we rise to the challenge to make a difference — and here’s how this role will make an impact:**Key Responsibilities*** Support SAP S/4HANA implementation, including data preparation, migration activities, testing (UAT/BRT), and hyper care.* Contribute to Master Data Governance (MDG) initiatives, including system enhancements, MDG retrofit activities, testing, and user training.* Support data migration and system integration activities, ensuring data accuracy and consistency across systems.* Create and maintain vendor and customer master data in line with global standards, governance policies, and SLAs.* Act as subject matter expert for master data topics and collaborate with cross-functional stakeholders to resolve issues.* Ensure high data quality through regular audits, DQM analysis, data cleansing, and deduplication activities.* Develop and maintain SOPs, process documentation, and training materials to support standardized ways of working.* Gather business requirements, execute test cases, and support system improvements and new functionalities.* Provide training and guidance to end users to ensure effective adoption of tools and processes.* Identify, escalate, and resolve data quality and process issues, driving continuous improvement.**Skills & Experience*** Proven experience in a master data management role, focused on vendor/customer master data.* Hands-on experience with SAP ERP systems is required; SAP S/4HANA experience is a prerequisite.* experience with Ariba/ Vertex would be a plus* Experience with Business Partner (BP) transformation in S/4HANA, including migration from legacy customer/vendor records (ECC), BP role configuration, and integration with procurement and finance modules.* Experience with processing mass creations/updates preferably with the usage of SAP GUI scripting is a plus* Strong attention to detail and a consistent track record of delivering high-quality, accurate data.* Excellent analytical skills, with the ability to interpret data and optimize processes.* Proficiency in Microsoft Office, especially Excel; experience with SQL is a plus.* Ability to work effectively in ambiguous environments and bring structure to complex challenges.* Strong organizational and time management skills.* Excellent communication skills, both written and verbal.* Proven ability to work collaboratively across functions and cultures.* Bachelor’s degree in a relevant discipline or equivalent professional experience.* Strong customer service orientation and stakeholder engagement skillsAt Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.Bei Viatris, bieten wir wettbewerbsfähige Gehälter, Sozialleistungen und ein integratives Umfeld, in dem Sie Ihre Erfahrungen, Perspektiven und Fähigkeiten einsetzen können, um das Leben anderer zu beeinflussen. #J-18808-Ljbffr
Ein führendes Gesundheitsunternehmen in Dublin sucht einen QC Analysten für einen Vertrag von 12 Monaten. In dieser Rolle sind Sie verantwortlich für die Analyse von Rohstoffen sowie die Durchführung von Qualitätskontrollen in der Produktion. Der ideale Kandidat hat einen Bachelorabschluss sowie mindestens 2 Jahre Erfahrung in einem Mikrobiologielabor. Sie bringen effektive Problemlösungsfähigkeiten mit und sind leidenschaftlich daran interessiert, die Qualität stets zu verbessern. Das Unternehmen bietet ein wettbewerbsfähiges Gehalt und ein integratives Arbeitsumfeld. #J-18808-Ljbffr
A leading pharmaceutical company in Dublin is seeking a Quality Systems Specialist to develop and implement quality systems that support the manufacture and release of products. The role requires a degree and 3+ years of experience, along with expertise in EU & US regulatory requirements. Experience in quality systems design is a plus. Competitive salaries and benefits are offered in an inclusive environment where skills and experiences can make a real impact. #J-18808-Ljbffr
Una empresa de farmacéutica global en Dublín está en busca de un Senior QC Analyst. Este rol incluye la responsabilidad de analizar materias primas, productos en proceso y finales, así como revisar datos analíticos y realizar validaciones de métodos. Se requiere un título en Ciencias y experiencia previa en entornos de laboratorio, así como el dominio del inglés. La posición se ofrece en un entorno inclusivo con competitivos beneficios. #J-18808-Ljbffr
Senior Manager, Regulatory Affairs page is loaded## Senior Manager, Regulatory Affairslocations: Northern Cross, Dublin, Irelandtime type: Tiempo completoposted on: Publicado hoyjob requisition id: R5665831McDermott Laboratories LimitedEn VIATRIS, vemos la atención médica no como es, sino como debería de ser. Actuamos con valentía y estamos en una posición única para ser una fuente de estabilidad en un mundo de necesidades de atención médica en constante evolución.Viatris ayuda a las personas de todo el mundo a vivir de manera más saludable en cada etapa de la vida.Lo hacemos a través de:Acceso – suministrando medicamentos de confianza y de alta calidad independientemente de la geografía o las circunstancias;Liderazgo – promoviendo operaciones sostenibles y soluciones innovadoras para mejorar la salud del paciente;Colaboración – aprovechando nuestra experiencia común para conectar a las personas con productos y servicios.Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.**The Role & What You Will Be Doing**The Senior Manager Global Branded CMC Strategy possesses CMC regulatory knowledge and quality expertise to independently prepare regulatory assessments & contribute to global regulatory strategies for projects across all aspects of drug development or manufacturing lifecycle and works to support the Upjohn portfolio.Every day, we rise to the challenge to make a difference and here’s how the **Senior Manager, Regulatory Affairs**role will make an impact:* Ensure global regulatory compliance with external requirements and internal quality procedures across all markets.* Apply sound regulatory judgment, strategic thinking, and business acumen to develop and implement global regulatory strategies.* Prepare, review, and deliver high-quality CMC submissions for new registrations, post-approval changes, renewals, and responses to agency queries.* Lead CMC activities for assigned projects, including submission planning, risk assessment, and regulatory timelines tracking.* Represent CMC on cross-functional project teams, ensuring alignment with scientific, technical, and regulatory criteria.* Maintain up-to-date regulatory documentation and systems, manage commitments, and ensure submission compliance.* Collaborate effectively with internal and external stakeholders, including Regulatory, Quality, R&D, and global/regional teams.* Serve as a technical and scientific resource for complex regulatory issues and provide mentoring to colleagues.* Support implementation of regulatory policies, procedures, and continuous improvement initiatives across CMC functions.* Build and maintain professional relationships with regulatory authorities and industry bodies to enhance regulatory success.* Contribute to CMC-related projects, training, and development programs, while modeling Viatris’ values and behaviors.* Participate in external forums, trade groups, or industry conferences relevant to CMC functions as needed.**About Your Skills & Experience**For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:* Mandatory hands-on CMC authoring experience (initial registrations or post-approval variations)* Sufficient level of knowledge and solid understanding of the development and commercial activities and cGMP’s required to assess technical, scientific and regulatory merits of CMC information, commitments and data to lead teams and/or project(s).* Advanced technical, functional, and industry knowledge to shape strategic direction of assigned project(s), reduce regulatory burden and improve regulatory flexibility commensurate with business needs.* Advanced knowledge of regulatory requirements and expectations, criteria for submission and approval globally and experience of interactions with regulatory authorities for projects.* Sound understanding and advanced knowledge of the principles, practices and concepts of regulatory CMC/ policy/ publishing disciplines and a working knowledge of the principles, practices, concepts and operations in other relevant disciplines.* Advanced skills in written & oral communications (mandatory).* Computer literacy with Microsoft Office Suite and Documentum-based applications.* Project Management skills* Ability to engage in the external regulatory and pharmaceutical environment.* Some experience serving as a Subject Matter Expert in specific relevant disciplines or as a resource for specific pharmaceutical science projects in specific regulatory domain(s).At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.**Diversity & Inclusion at Viatris**At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit**Sustainability at Viatris**Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visitEn Viatris, ofrecemos salarios competitivos, beneficios y un entorno inclusivo donde puede usar sus experiencias, perspectivas y habilidades para ayudar a generar un impacto en la vida de los demás.Viatris es una compañía global del cuidado de la salud creada en 2020 a través de la combinación de Mylan y Upjohn, una división legada de Pfizer. Al integrar las fortalezas de estas dos compañías, incluida nuestra fuerza laboral global de aprox. 45,000, nuestro objetivo es proporcionar acceso mejorado a medicamentos de calidad asequibles a pacientes de todo el mundo, independientemente de dónde vivan o de las circunstancias. Creemos en el cuidado de la salud como debe ser: empoderamos a las personas de todo el mundo para que vivan de manera más saludable en cada etapa de la vida. Debido a nuestra creencia firme de que un acceso mejorado permite una mejor salud, aprovechamos nuestra experiencia científica y de manufactura inmejorable, al igual que las capacidades comerciales comprobadas, para ofrecer a los pacientes medicamentos de calidad en el momento y en el lugar que los necesiten. #J-18808-Ljbffr
